A traditional Chinese medicine composition and traditional Chinese medicine preparation for treating Parkinson's disease with deficiency of yin and wind moving

Abstract

The application belongs to the field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition and a traditional Chinese medicine preparation for treating Parkinson's disease with wind due to yin deficiency, which is composed of the following raw materials in parts by weight: rehmannia 15-30 parts, turtle shell 10-25 parts, Gastrodia 6-15 parts, mother-of-pearl 15-30 parts, ligustrum 10-20 parts, euphorbia humifusa 10-20 parts, acanthopanax 10-20 parts, turmeric 6-15 parts, radix mori 15-30 parts, nine-node calamus 3-10 parts, and polygala 6-12 parts. The traditional Chinese medicine composition treats Parkinson's disease from the perspective of wind due to yin deficiency and toxin damaging the brain collaterals, and establishes the treatment method of nourishing yin to extinguish wind, calming the nerves to stabilize tremor, and removing toxin to dredge the collaterals based on the theory system of pattern identification. The traditional Chinese medicine composition can effectively improve the motor function and sleep disorders, anxiety and depression and other non-motor symptoms of Parkinson's disease patients, and solves the problem that the existing traditional Chinese medicine prescriptions cannot simultaneously consider the motor symptoms and non-motor symptoms and have poor comprehensive improvement effect on the two types of symptoms.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine compositions, and more specifically, relates to a traditional Chinese medicine composition and preparation for treating Parkinson's disease with yin deficiency and wind-stirring syndrome. Background Technology

[0002] Parkinson's disease (PD) is a common neurodegenerative disease affecting middle-aged and elderly people. It is a slowly progressive neurodegenerative disease characterized primarily by the progressive degeneration of dopaminergic neurons in the substantia nigra of the midbrain, involving multiple systems. The main clinical manifestations of PD include motor symptoms such as bradykinesia, resting tremor, muscle rigidity, and postural and gait disturbances, as well as non-motor symptoms such as cognitive and emotional disturbances, sleep disturbances, anxiety, constipation, pain, and fatigue. The motor and non-motor symptoms of PD cause a range of functional impairments of varying degrees, severely impacting patients' daily living activities, leading to a decline in quality of life and loss of work capacity.

[0003] Currently, the treatment of Parkinson's disease (PD) mainly focuses on drug therapy and surgery. Drug therapy is the primary treatment method for PD, with medications such as dopaminergic valerate tablets, carbapenem / levodopa controlled-release tablets, pramipexole hydrochloride tablets, piribedil extended-release tablets, entacapone tablets, and selegiline hydrochloride tablets commonly used in clinical practice. Although oral medications can alleviate some symptoms and signs of PD in clinical practice, the use of medication alone cannot avoid side effects such as muscle rigidity, bradykinesia, on-off phenomena, and dyskinesia in PD patients. Other therapies, such as surgical treatment, mainly include deep brain stimulation of the subthalamic nucleus (STN-DBS) and embryonic pluripotent neural stem cell transplantation. Some of these therapies are still in the experimental research stage and have not been widely implemented in clinical practice. They also have drawbacks such as relatively poor long-term efficacy, more complications, and high cost, which to some extent limit their clinical application.

[0004] In recent years, Traditional Chinese Medicine (TCM) has played a stabilizing role in the treatment of Parkinson's disease (PD) due to its unique advantages of multi-target, multi-level, multi-effect, and fewer adverse reactions. Existing patents disclose various TCM compound formulas for treating Parkinson's disease. For example, Chinese patent application number 2007100547916 discloses a TCM preparation for treating Parkinson's disease composed of Rehmannia glutinosa, Lycium barbarum, Ginseng, Salvia miltiorrhiza, Dragon's Blood, Leech, Gastrodia elata, Uncaria rhynchophylla, Arisaema cum Bile, Alisma plantago-aquatica, Aristolochia debilis, Aquilaria sinensis, and Styrax benzoin; Chinese patent application number 2007100763667 discloses a TCM preparation for treating Parkinson's disease made from red ginseng, Ginkgo biloba, Lycium barbarum, Acanthopanax senticosus, Schisandra chinensis, Polygonum multiflorum, Uncaria rhynchophylla, raw oyster shell, Salvia miltiorrhiza, and Scutellaria baicalensis; application number... Chinese Patent No. 2008101116349 discloses a traditional Chinese medicine composition for treating Parkinson's disease, consisting of Rehmannia glutinosa, Paeonia lactiflora, Paeonia veitchii, Angelica sinensis, Spatholobus suberectus, Prunus persica, Codonopsis pilosula, Gastrodia elata, Astragalus membranaceus, pearl powder, Uncaria rhynchophylla, Salvia miltiorrhiza, Carthamus tinctorius, Rehmannia glutinosa, Caesalpinia sappan, and bamboo sap; Chinese Patent No. 2013105844204 discloses a traditional Chinese medicine composition for treating Parkinson's disease, consisting of Gastrodia elata, Uncaria rhynchophylla, Scorpio, Pheretima aspergillum, Cicadae periostracum, Bombyx mori, Panax ginseng, Astragalus membranaceus, Spatholobus suberectus, Tortoise shell, Deer antler glue, Psoralea corylifolia, Panax notoginseng, Ligusticum chuanxiong, and Salvia miltiorrhiza. However, existing Chinese medicine prescriptions mostly focus on tonifying the liver and kidneys, nourishing yin and extinguishing wind, extinguishing wind and stopping tremors, promoting blood circulation and extinguishing wind, and replenishing qi and nourishing blood. They do not combine traditional Chinese medicine syndrome differentiation to carry out targeted prescription design, and do not fully take into account the treatment needs of Parkinson's disease patients such as sleep disorders, cognitive decline, and emotional abnormalities, resulting in poor treatment effects.

[0005] Chinese patent application number 202211069278.5 discloses a traditional Chinese medicine composition for treating non-motor symptoms related to Parkinson's disease, consisting of processed turtle shell, prepared rehmannia root, privet fruit, white peony root, gastrodia rhizome, uncaria rhizome, angelica root, silkworm, jujube seed, calcined oyster shell, turmeric, and alpinia oxyphylla. However, this approach mainly focuses on differentiating and treating the types and characteristics of non-motor symptoms in Parkinson's syndrome, and its effect on improving the main symptoms of Parkinson's disease is not ideal.

[0006] It is evident that existing traditional Chinese medicine formulas for treating Parkinson's disease are insufficient to improve non-motor symptoms while simultaneously addressing the main symptoms of the disease. Currently, there is a lack of a traditional Chinese medicine compound formula for treating PD that can address both the root cause and the symptoms, and harmonize the state and target. Summary of the Invention

[0007] In view of the shortcomings and deficiencies of existing technologies, this invention, based on a systematic understanding of the core pathogenesis of Parkinson's disease, namely "yin deficiency and wind stirring, with toxins damaging the brain network," and combined with the theory of "state-target differentiation," provides a traditional Chinese medicine composition and preparation for treating Parkinson's disease with yin deficiency and wind stirring syndrome. This overcomes the shortcomings of existing traditional Chinese medicine compound prescriptions, which often focus on "stopping tremors" and neglect the treatment needs of Parkinson's disease involving multiple systems and non-motor symptoms. The provided traditional Chinese medicine composition is based on the theory of "state-target differentiation." At the macroscopic level, its therapeutic effect closely addresses the core pathogenesis of Parkinson's disease, namely "yin deficiency and wind stirring, with toxins damaging the brain network." At the microscopic level, it precisely targets key pathological links such as dopaminergic neuron damage, neuroinflammation and oxidative stress, and non-motor symptoms. It deeply integrates the holistic view of traditional Chinese medicine with the concept of modern precision medicine, achieving both symptomatic and root cause treatment, and harmonizing state and target, thus comprehensively improving both motor and non-motor symptoms of Parkinson's disease.

[0008] To achieve the above objectives, the present invention adopts the following technical solution: A traditional Chinese medicine composition for treating Parkinson's disease with Yin deficiency and wind-stirring syndrome, the composition comprising the following raw materials in parts by weight: 15-30 parts of Rehmannia glutinosa, 10-25 parts of turtle shell, 6-15 parts of Gastrodia elata, 15-30 parts of pearl powder, 10-20 parts of Ligustrum lucidum, 10-20 parts of Eclipta prostrata, 10-20 parts of Acanthopanax senticosus, 6-15 parts of Curcuma longa, 15-30 parts of Polygonum multiflorum vine, 3-10 parts of Acorus tatarinowii, and 6-12 parts of Polygala tenuifolia.

[0009] As a preferred technical solution of the present invention, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 25-30 parts of Rehmannia glutinosa, 20-25 parts of turtle shell, 12-15 parts of Gastrodia elata, 25-30 parts of pearl powder, 15-20 parts of Ligustrum lucidum, 15-20 parts of Eclipta prostrata, 10-15 parts of Acanthopanax senticosus, 6-10 parts of Curcuma longa, 15-20 parts of Polygonum multiflorum vine, 3-6 parts of Acorus tatarinowii, and 6-9 parts of Polygala tenuifolia. The traditional Chinese medicine composition is suitable for the type of Yin deficiency with Yang hyperactivity and significant wind stirring.

[0010] As a preferred technical solution of the present invention, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15-20 parts of Rehmannia glutinosa, 10-15 parts of turtle shell, 9-12 parts of Gastrodia elata, 15-20 parts of pearl powder, 10-15 parts of Ligustrum lucidum, 10-15 parts of Eclipta prostrata, 15-20 parts of Acanthopanax senticosus, 10-15 parts of Curcuma longa, 25-30 parts of Polygonum multiflorum vine, 6-10 parts of Acorus tatarinowii, and 9-12 parts of Polygala tenuifolia. The traditional Chinese medicine composition is suitable for the type of Yin deficiency with wind stirring, phlegm and blood stasis obstructing the collaterals, and mental disturbance.

[0011] As a preferred technical solution of the present invention, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of Rehmannia glutinosa, 15 parts of turtle shell, 10 parts of Gastrodia elata, 20 parts of pearl powder, 15 parts of Ligustrum lucidum, 15 parts of Eclipta prostrata, 15 parts of Acanthopanax senticosus, 10 parts of Curcuma longa, 20 parts of Polygonum multiflorum vine, 6 parts of Acorus tatarinowii, and 10 parts of Polygala tenuifolia; the traditional Chinese medicine composition is suitable for the type of Yin deficiency with wind stirring and concurrent but not obvious symptoms.

[0012] As a preferred technical solution of the present invention, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of Rehmannia glutinosa, 15 parts of turtle shell, 12 parts of Gastrodia elata, 30 parts of pearl powder, 15 parts of Ligustrum lucidum, 15 parts of Eclipta prostrata, 15 parts of Acanthopanax senticosus, 10 parts of Curcuma longa, 30 parts of Polygonum multiflorum vine, 6 parts of Acorus tatarinowii, and 12 parts of Polygala tenuifolia; the traditional Chinese medicine composition is suitable for the type of insomnia with yin deficiency and wind stirring.

[0013] This invention also provides a traditional Chinese medicine preparation for treating Parkinson's disease with yin deficiency and wind-stirring syndrome. The traditional Chinese medicine preparation is any one of oral preparations such as decoction, granules, tablets, pills, capsules, powders, and oral liquids. The traditional Chinese medicine preparation is prepared using the above-mentioned traditional Chinese medicine composition.

[0014] As a preferred technical solution of the present invention, the traditional Chinese medicine preparation is a decoction. The preparation method of the decoction includes the following steps: cleaning and selecting the medicinal materials; crushing the turtle shell and mother-of-pearl, first putting them into a clay pot, adding enough cold water, and decocting for 15-30 minutes; then adding the remaining medicinal materials to the clay pot that was decocted first, adding cold water until it covers the medicinal materials, bringing it to a boil over high heat, then reducing the heat to low and maintaining a simmer for 40-60 minutes, pouring out the first decoction, filtering it with two layers of gauze, and storing it in a clean container; for the second decoction, adding warm water to the dregs until it covers the dregs, bringing it to a boil over high heat, then reducing the heat to low and maintaining a simmer for 30-40 minutes, filtering, and mixing the filtered decoction with the first decoction.

[0015] The "state-target differentiation" theory mentioned in this invention is based on the core model of "macro-level state regulation and micro-level target targeting." "State" refers to the overall pathological state, dynamic evolution process, and development trend of a disease at a certain stage, representing a macro-level grasp of the core pathogenesis throughout the entire disease process. "Target" is divided into three levels: disease target (targeted prescriptions and drugs for specific diseases), state target (state-regulating drugs targeting the core pathogenesis of each stage), and standard target (precise intervention targeting physicochemical or imaging indicators). In clinical practice, diseases are first classified according to modern medical diagnoses, then their dynamic evolution patterns are grasped to extract the core pathogenesis (state) of each stage, while simultaneously combining objective indicators (targets), ultimately forming a treatment plan that "harmonizes state and target, and considers both cause and effect."

[0016] The traditional Chinese medicine composition provided by this invention uses "nourishing yin and extinguishing wind, calming the mind and relieving tremors, and detoxifying and unblocking the meridians" as its basic treatment principle and "regulating both state and target" as its formulation principle. The formulation analysis is as follows: From the perspective of "regulating the state": This formula closely addresses the core pathological state of Parkinson's disease, namely "yin deficiency and wind stirring, with toxins damaging the brain's collaterals," and achieves macroscopic regulation on three levels. First, it nourishes the kidneys and replenishes yin to regulate the "deficient state." The formula uses four herbs—Rehmannia glutinosa, turtle shell, Ligustrum lucidum, and Eclipta prostrata—to nourish the kidneys, replenish yin, and benefit essence and marrow, directly addressing the root cause of Parkinson's disease, which often occurs in middle-aged and elderly people, and is caused by kidney essence deficiency. Rehmannia glutinosa is sweet and cold in nature, entering the heart, liver, and kidney meridians. It excels at clearing heat and cooling blood, nourishing yin and generating fluids. The *Shennong Bencao Jing* states that it "treats fractures and sprains, internal injuries, expels blood stasis, fills bone marrow, and promotes muscle growth." Trionyx sinensis is salty and slightly cold in nature, entering the liver and kidney meridians. It nourishes yin and subdues yang, reduces fever and eliminates steaming sensations. The *Bencao Jing Shu* states that it "enters the liver and kidneys, effectively breaks up masses and also nourishes yin." Ligustrum lucidum and Eclipta prostrata are used in the Erzhi Wan formula to gently tonify the yin of the liver and kidneys. When used together, their yin-nourishing power is doubled. When these four herbs are used together, kidney essence is replenished, the marrow is nourished, and the brain is properly governed; this is how the "deficiency state" is regulated. Secondly, it calms the liver and subdues yang to regulate the "wind state." Gastrodia elata is combined with pearl powder; one extinguishes wind and stops spasms, while the other heavily calms and subdues yang. Gastrodia elata is sweet and neutral in nature, entering the liver meridian. The *Compendium of Materia Medica* states that "Gastrodia elata is a medicine for the qi aspect of the liver meridian," and the *Suwen* (Plain Questions) states that "all dizziness and vertigo belong to the liver," indicating that Gastrodia elata specifically treats symptoms of internal liver wind. Mother-of-pearl is salty and cold in nature, entering the heart and liver meridians, calming the liver and suppressing yang, and soothing the mind. The *Chinese Pharmacopoeia* records that it "calms the mind and soothes the heart, calms the liver and suppresses yang." The combination of these two herbs extinguishes internal wind and suppresses floating yang, thus regulating the "wind state." Thirdly, it resolves phlegm, invigorates blood, detoxifies, and unblocks the meridians to regulate the state of "toxin-damaged brain meridians." Parkinson's disease has a protracted course; "prolonged illness enters the meridians," and "prolonged illness often leads to blood stasis." Deficiency leads to blood stasis, and prolonged blood stasis generates toxins, which damage the brain meridians and is key to the progression and aggravation of the disease. Acanthopanax senticosus is sweet, slightly bitter, and warm in nature, entering the spleen, kidney, and heart meridians, tonifying qi and strengthening the spleen, nourishing the kidneys and calming the mind. The *Northeast Medicinal Plants* records that it "tonifies qi and strengthens the spleen, nourishes the kidneys and calms the mind." Its qi-boosting effect can help blood circulation; turmeric is bitter and warm in nature, entering the liver and spleen meridians, breaking up blood stasis, promoting qi circulation, and relieving pain. The Tang Materia Medica records that it "breaks up blood stasis, promotes qi circulation, and relieves pain." The two herbs combined can resolve the harm of "blood stasis and toxins." Polygonum multiflorum vine is sweet and neutral in nature, entering the heart and liver meridians, nourishing blood, calming the mind, and guiding yang into yin. The Compendium of Materia Medica states that it "guides yang into yin, which is the most stable," targeting the prominent sleep disorders of Parkinson's disease patients; Acorus calamus is the dried rhizome of the Ranunculaceae plant Anemone altaica, which is pungent and slightly warm in nature, entering the heart, liver, and spleen meridians, and is good at resolving phlegm, opening the orifices, and invigorating the spleen and calming the mind; Polygala tenuifolia is bitter and warm in nature, entering the heart, kidney, and lung meridians, resolving phlegm, opening the orifices, calming the mind, and improving intelligence. The Compendium of Materia Medica states that it "can promote kidney qi and reach the heart, thus it is an essential medicine for harmonizing the heart and kidneys." When the five medicines are used together, phlegm and turbidity are resolved, blocked orifices are opened, the mind and spirit are calmed, and blood stasis and toxins are eliminated. This is how the state of "toxins damaging the brain's collaterals" is restored.

[0017] From a "targeting" perspective: This formula achieves precise intervention targeting key pathological aspects of Parkinson's disease. Modern pharmacological studies have shown that active ingredients such as rehmannia glutinosa and rehmannia glycosides in Rehmannia glutinosa have effects such as anti-oxidative stress, inhibition of cell apoptosis, and regulation of neurotrophic factor expression, and can target and protect dopaminergic neurons; turtle shell is rich in collagen and various amino acids, which can nourish nerve tissue; privet fruit can inhibit oxidative stress damage in Parkinson's disease models and alleviate inflammatory responses; gastrodin in Gastrodia elata has antioxidant, anti-inflammatory, and neurotransmitter-regulating effects; Acanthopanax senticosus can exert neuroprotective effects by regulating the expression of apoptosis-related proteins such as Bax / Bcl-2 and Caspase-3; curcumin in turmeric is a recognized anti-inflammatory and antioxidant active ingredient; Polygonum multiflorum can regulate neurotransmitter balance and improve sleep; Acorus tatarinowii has sedative and anticonvulsant effects, and Polygala tenuifolia has the effects of improving cognitive function and antidepressant effects. The aforementioned drugs target key pathological processes such as dopaminergic neuron damage, neuroinflammation and oxidative stress, and non-motor symptoms, achieving an organic unity from macroscopic regulation to microscopic targeting.

[0018] From the perspective of the "principal, assistant, adjuvant, and guide" combination: This formula uses Gastrodia elata and Carapax Trionycis as the principal herbs. Gastrodia elata calms the liver, extinguishes wind, unblocks the channels, and stops spasms, directly addressing the superficial manifestation of "wind movement"; Carapax Trionycis nourishes yin, subdues yang, softens hardness, and dissipates nodules, targeting the root cause of "yin deficiency." These two herbs, one subduing and the other extinguishing, address both the symptoms and the root cause, thus serving as the principal herbs. Rehmannia glutinosa, Ligustrum lucidum, Eclipta prostrata, and Margarita are the assistant herbs. Rehmannia glutinosa, Ligustrum lucidum, and Eclipta prostrata nourish the kidneys and replenish yin, assisting Carapax Trionycis in replenishing true yin; Margarita calms and subdues yang, assisting Gastrodia elata in extinguishing internal wind. The four herbs combined enhance the yin-nourishing and yang-subduing effects of the principal herbs. Acanthopanax senticosus, Curcuma longa, and Polygonum multiflorum are the adjuvant herbs. Acanthopanax senticosus invigorates qi and blood to help resolve blood stasis and unblock the channels; Curcuma longa breaks up blood stasis and promotes qi circulation to relieve stagnation and toxins; Polygonum multiflorum nourishes blood and calms the mind to regulate mental disturbances. The three herbs combined assist the principal and assistant herbs in addressing the harms of "blood stasis and toxins" and "channel damage." Nine-jointed calamus and polygala are used as guiding herbs. Nine-jointed calamus excels at resolving phlegm and opening the orifices, guiding the medicine upwards to the clear orifices and invigorating the spleen and stomach; polygala dispels phlegm, calms the mind, and harmonizes the heart and kidneys, thus regulating water and fire. The combination of these two herbs not only guides other medicines directly to the affected area but also harmonizes the heart and kidneys, calms the mind, and stabilizes the will, while also harmonizing the effects of other herbs. The entire formula has a clear distinction between the principal, assistant, and adjuvant herbs, working together to nourish yin, extinguish wind, calm the mind, stop tremors, detoxify, and unblock the meridians.

[0019] Small-sample clinical observations have confirmed that the traditional Chinese medicine composition provided by this invention can effectively improve motor function and non-motor symptoms such as sleep disorders, anxiety, and depression in patients with Parkinson's disease. After taking the medication, patients experienced significant relief from motor symptoms such as limb tremors and muscle rigidity, significantly improved sleep quality, more stable emotions, and improved quality of life. Furthermore, the medication was well-tolerated by patients, and no significant adverse reactions were observed.

[0020] In summary, the traditional Chinese medicine composition of the present invention has the following advantages and beneficial effects: (1) Based on a systematic understanding of the core pathogenesis of Parkinson's disease, namely "yin deficiency causing wind and toxin damaging brain collaterals", this invention establishes the treatment method of nourishing yin and extinguishing wind, detoxifying and unblocking collaterals. The prescription is rigorous, and the theory, method, prescription and medicine are integrated. It breaks through the traditional Chinese medicine compound prescription treatment idea of ​​"stopping tremors" and realizes the comprehensive intervention of multiple systems affected by Parkinson's disease.

[0021] (2) This formula fully embodies the characteristics of "state-target coordination". At the macro level, it comprehensively regulates the state from multiple dimensions such as "deficiency state", "wind state" and "toxic damage state". At the micro level, it precisely intervenes in key targets such as dopaminergic neuron damage, neuroinflammation and oxidative stress, and non-motor symptoms, thus realizing the organic integration of the holistic view of traditional Chinese medicine and modern precision medicine.

[0022] (3) The traditional Chinese medicine composition provided by the present invention mainly improves motor symptoms. While improving motor symptoms, it pays special attention to the treatment needs of non-motor symptoms of Parkinson's disease patients. The combination of drugs such as Polygonum multiflorum, Acorus tatarinowii, and Polygala tenuifolia has a significant effect on improving non-motor symptoms such as sleep disorders and emotional abnormalities (anxiety and depression) that are common in patients. It makes up for the shortcomings of existing anti-Parkinson's disease Western medicines, which can only improve motor symptoms well and have limited efficacy on various non-motor symptoms. At the same time, existing traditional Chinese medicine prescriptions are difficult to take into account both motor symptoms and non-motor symptoms, and the comprehensive improvement effect on the two types of symptoms is not good.

[0023] (4) The traditional Chinese medicine composition provided by the present invention can significantly improve the motor symptoms of Parkinson's disease patients (UPDRS-II and UPDRS-III scores are significantly reduced). After 8 weeks of treatment, the total effective rate of the treatment group reached 88.46%, which was significantly higher than that of the control group (48.15%). In terms of non-motor symptoms, the NMSS score of the treatment group decreased from 52.37±18.46 before treatment to 25.88±13.67 (P<0.01). The total improvement rate of non-motor symptoms, as calculated by the NMSS reduction rate, reached 92.31%, which was significantly better than that of the control group (40.74%) (P<0.01). It can better meet the treatment needs of Parkinson's disease patients to improve motor and non-motor symptoms.

[0024] (5) The traditional Chinese medicine composition provided by the present invention has a particularly prominent effect on improving non-motor symptoms such as sleep disorders, anxiety and depression in patients with Parkinson's disease. The PDSS score increased from 89.67±18.34 to 120.73±16.88 (P<0.01), the HAMA score decreased from 16.37±5.24 to 8.73±3.96 (P<0.01), and the HAMD-17 score decreased from 18.43±6.12 to 9.88±4.52 (P<0.01), which can significantly improve the quality of life of patients.

[0025] (6) Through observation of typical cases, it was found that the traditional Chinese medicine composition provided by the present invention also has an effect on improving cognitive function when targeted treatment is given to patients with different syndrome types. For patients with mild cognitive impairment, cognitive function can basically be restored to normal after treatment.

[0026] (7) The medicinal materials used in the traditional Chinese medicine composition provided by the present invention are mild in nature, safe, and have no obvious adverse reactions, making them suitable for long-term use. Detailed Implementation

[0027] The present invention will be further described in detail below with reference to embodiments and clinical trials, but the scope of protection of the present invention is not limited thereto. Those skilled in the art can make appropriate adjustments and optimizations to the component ratios or preparation processes according to actual circumstances, and all equivalent substitutions and improvements based on the present invention should be considered as included within the scope of protection of the present invention. The clinical observation cases involved in this section are from outpatients and inpatients of the Affiliated Hospital of Changchun University of Traditional Chinese Medicine.

[0028] Example 1:

[0029] This embodiment provides a traditional Chinese medicine composition for treating Parkinson's disease with Yin deficiency and wind-stirring syndrome. The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 20g Rehmannia glutinosa, 15g turtle shell, 10g Gastrodia elata, 20g pearl powder, 15g Ligustrum lucidum, 15g Eclipta prostrata, 15g Acanthopanax senticosus, 10g Curcuma longa, 20g Polygonum multiflorum vine, 6g Acorus tatarinowii, and 10g Polygala tenuifolia. This formula is a basic formula, suitable for Yin deficiency and wind-stirring syndrome with mild or no obvious symptoms. The dosage of the drugs is moderate, with a balanced approach of tonifying and purging, and a combination of tonifying and purging.

[0030] This formula is based on the core pathogenesis of Parkinson's disease: "Yin deficiency and wind stirring, toxins damaging the brain's collaterals." Gastrodia elata and turtle shell are the principal herbs. Gastrodia elata is sweet and neutral in nature, entering the liver meridian. It extinguishes wind, stops spasms, and calms liver yang. The *Compendium of Materia Medica* states that "Gastrodia elata is a medicine for the Qi aspect of the liver meridian," and the *Suwen* states that "all wind-related dizziness and vertigo belong to the liver." Gastrodia elata specifically treats symptoms of internal liver wind stirring. Modern research shows that gastrodin is one of the main active components of Gastrodia elata that exerts its dopaminergic neuroprotective effect, exerting its anti-Parkinson's disease effect through multiple target pathways, including anti-oxidative stress, improving mitochondrial function, inhibiting cell apoptosis, and reducing neuroinflammation. Turtle shell is salty and slightly cold in nature, entering the liver and kidney meridians. It nourishes yin, subdues yang, reduces fever, and eliminates steaming sensations. The *Commentary on the Materia Medica* states that it "enters the liver and kidneys, effectively breaking up masses and also nourishing yin." These two herbs, one subduing and the other extinguishing, address both the root cause and the symptoms, and together serve as the principal herbs. Rehmannia glutinosa, Ligustrum lucidum, Eclipta prostrata, and mother-of-pearl are the assistant herbs. Rehmannia glutinosa, sweet and cold in nature, enters the heart, liver, and kidney meridians. It excels at clearing heat and cooling the blood, nourishing yin and generating fluids. The *Shennong Bencao Jing* states that it "treats fractures and sprains, internal injuries, dispels blood stasis, replenishes bone marrow, and promotes muscle growth." Its active ingredient, catalpol, has antioxidant, anti-inflammatory, anti-apoptotic, and neuroprotective effects, showing significant preventative and therapeutic effects on neurodegenerative diseases such as Parkinson's disease. Ligustrum lucidum and Eclipta prostrata are used in the Erzhi Wan formula to gently nourish the yin of the liver and kidneys. Mother-of-pearl, salty and cold in nature, enters the heart and liver meridians, calming the liver and suppressing yang, and soothing the mind. The *Chinese Pharmacopoeia* records that it "calms the mind and soothes the heart, calms the liver and suppresses yang." The combination of these four herbs enhances the yin-nourishing and yang-suppressing effects of the principal herb. Acanthopanax senticosus, turmeric, and Polygonum multiflorum vine are used as adjuvant herbs. Eleutherococcus senticosus has a sweet and slightly bitter taste and is warm in nature. It enters the spleen, kidney, and heart meridians, and invigorates qi and strengthens the spleen, tonifies the kidneys and calms the mind. Modern research shows that Eleutherococcus senticosus extract can regulate sphingolipid metabolism and glycerophospholipid metabolism, inhibit α-syn aggregation, upregulate TH expression, and improve motor and neurodegenerative diseases in Parkinson's disease. Curcuma longa has a bitter and pungent taste and is warm in nature. It enters the liver and spleen meridians, and promotes blood circulation, regulates qi, and relieves pain. The Tang Materia Medica states that it "promotes blood circulation, regulates qi, and relieves pain." Curcumin can inhibit α-syn aggregation by inhibiting neuroinflammation and oxidative stress, and improve motor coordination in Parkinson's disease. Polygonum multiflorum has a sweet taste and is neutral in nature. It enters the heart and liver meridians, and nourishes blood, calms the mind, and guides yang into yin. The Bencao Zhengyi states that it "guides yang into yin, and is the most stable." Acorus tatarinowii and Polygala tenuifolia are used as guiding herbs. Nine-jointed calamus, bitter and slightly warm in nature, enters the heart, liver, and spleen meridians. It excels at resolving phlegm and opening the orifices, guiding the medicine upwards to the clear orifices and in the middle to the spleen and stomach. Polygala tenuifolia, bitter and warm in nature, enters the heart, kidney, and lung meridians. It resolves phlegm, opens the orifices, calms the mind and improves intelligence. The "Correct Interpretation of Materia Medica" states that it "can invigorate kidney qi and reach the heart, thus it is an essential medicine for harmonizing the heart and kidneys." Polygala tenuifolia can protect neurons and improve cognitive impairment through mechanisms such as reducing abnormal protein deposition, reducing the release of inflammatory factors, and alleviating oxidative stress damage.

[0031] The traditional Chinese medicine composition provided in this embodiment can be made into any one of granules, tablets, capsules, powders, decoctions or pills when actually taken. Decoctions are easy to prepare and are absorbed quickly. The following uses decoctions as an example to illustrate the preparation method.

[0032] The preparation method of the decoction described in this embodiment is as follows: Clean and select the medicinal herbs. Crush the turtle shell and mother-of-pearl, and place them in a clay pot with enough cold water to decoct for 20 minutes. Then add the remaining herbs to the clay pot, add cold water until it covers the herbs by about 3-4 cm, bring to a boil over high heat, then reduce to a simmer and decoct for 50 minutes. Pour out the first decoction, filter it through two layers of gauze, and store it in a clean container (about 150-200 ml). For the second decoction: add warm water to the dregs until it covers them by about 1-2 cm, bring to a boil over high heat, then reduce to a simmer and decoct for 35 minutes. Filter the decoction, and mix it with the first decoction (total volume about 300-400 ml). Stir well. Take twice daily, 150-200 ml each time after breakfast and dinner, warm. Avoid raw, cold, greasy, and spicy foods.

[0033] Example 2:

[0034] The traditional Chinese medicine composition for treating Parkinson's disease with yin deficiency and wind-stirring syndrome provided in this embodiment consists of the following raw materials in parts by weight: 25g Rehmannia glutinosa, 20g turtle shell, 12g Gastrodia elata, 25g pearl powder, 15g Ligustrum lucidum, 15g Eclipta prostrata, 10g Acanthopanax senticosus, 6g Curcuma longa, 15g Polygonum multiflorum vine, 3g Acorus tatarinowii, and 6g Polygala tenuifolia.

[0035] Compared to Example 1, this formulation increases the dosage of Rehmannia glutinosa, turtle shell, Gastrodia elata, and pearl powder, while reducing the dosage of Acanthopanax senticosus, Curcuma longa, Polygonum multiflorum vine, Acorus tatarinowii, and Polygala tenuifolia. The aim is to strengthen the "nourishing yin and suppressing yang, sedating wind" effect, and reduce the use of blood-activating and phlegm-resolving drugs to prevent depletion of yin fluids. This formulation is more suitable for Parkinson's disease with yin deficiency and yang hyperactivity, characterized by significant wind-related symptoms—typically manifested by large amplitude and high frequency of limb tremors, accompanied by dizziness, tinnitus, irritability, flushed face, red tongue with little coating, and a wiry, thready, and rapid pulse.

[0036] The preparation method of the decoction is the same as in Example 1.

[0037] Example 3:

[0038] The traditional Chinese medicine composition for treating Parkinson's disease with Yin deficiency and wind-stirring syndrome provided in this embodiment consists of the following raw materials in parts by weight: 15g Rehmannia glutinosa, 10g turtle shell, 9g Gastrodia elata, 15g pearl powder, 10g Ligustrum lucidum, 10g Eclipta prostrata, 20g Acanthopanax senticosus, 15g Curcuma longa, 30g Polygonum multiflorum vine, 10g Acorus tatarinowii, and 12g Polygala tenuifolia.

[0039] Compared to Example 1, this formulation increases the dosage of Acanthopanax senticosus, Curcuma longa, Polygonum multiflorum vine, Acorus tatarinowii, and Polygala tenuifolia, while reducing the dosage of Rehmannia glutinosa, Trionyx sinensis, Gastrodia elata, Margarita, Ligustrum lucidum, and Eclipta prostrata. The increased dosages of these herbs work synergistically: Acanthopanax senticosus invigorates qi to promote blood circulation, while Curcuma longa resolves blood stasis to unblock the meridians; together, they resolve the stagnation of "blood stasis and toxins." Polygonum multiflorum vine nourishes blood to calm the mind, Acorus tatarinowii resolves phlegm to open the orifices, and Polygala tenuifolia eliminates phlegm to harmonize the heart and kidneys; together, they regulate the state of "phlegm obstructing the orifices and disturbing the mind." The reduced dosages of yin-nourishing herbs aim to prevent yin-nourishing herbs from being cloying and hindering dampness, or promoting phlegm production, thus ensuring a smooth process of eliminating pathogens. This combination of increasing and decreasing, and tonifying and unblocking, not only uses Acanthopanax senticosus and turmeric to invigorate qi and blood, and remove blood stasis and unblock collaterals to relieve the stagnation of "toxins damaging the brain collaterals", but also uses Polygonum multiflorum vine, Acorus tatarinowii, and Polygala tenuifolia to resolve phlegm, open the orifices, calm the mind and stabilize the will to restore the normal state of "mental and spiritual disturbance". The combined use of these drugs is more suitable for the type of yin deficiency with wind stirring and phlegm and blood stasis obstructing collaterals and mental and spiritual disturbance - clinically characterized by stiff limbs, difficulty in flexion and extension, slow movement, insomnia at night, dreaming and easy to wake up, forgetfulness, slow reaction, dark tongue or petechiae, greasy tongue coating, and wiry and hesitant pulse.

[0040] The preparation method of the decoction is the same as in Example 1.

[0041] Example 4:

[0042] The traditional Chinese medicine composition for treating Parkinson's disease with Yin deficiency and wind-stirring syndrome provided in this embodiment consists of the following raw materials in parts by weight: 20g Rehmannia glutinosa, 15g Carapax Trionycis, 12g Gastrodia elata, 30g Margarita, 15g Ligustrum lucidum, 15g Eclipta prostrata, 15g Acanthopanax senticosus, 10g Curcuma longa, 30g Polygonum multiflorum vine, 6g Acorus tatarinowii, and 12g Polygala tenuifolia. Compared with Example 1, the main adjustments are as follows: Gastrodia elata is increased from 10g to 12g, and Margarita is increased from 20g to 30g. The two work synergistically to enhance the effects of calming the liver and suppressing Yang, and suppressing wind, in order to control the symptoms of internal wind-stirring syndrome; Polygonum multiflorum vine is increased from 20g to 30g, and Polygala tenuifolia is increased from 6g to 12g. The combination of the two enhances the effects of nourishing the heart and calming the mind, and harmonizing the heart and kidneys, in order to relieve the restlessness of the mind. The four herbs work together to calm the mind and soothe the nerves, thus suppressing excess yang, calming the mind, and extinguishing deficiency wind. This combination is especially suitable for those with yin deficiency and wind-induced insomnia.

[0043] To further verify the clinical efficacy of the herbal composition of the present invention on Parkinson's disease, an exploratory clinical observation was conducted using the decoction prepared in Example 1. The specific details are as follows: 1. General Information Sixty Parkinson's disease patients who were treated at the outpatient and inpatient departments of the Affiliated Hospital of Changchun University of Traditional Chinese Medicine from June 2024 to December 2025 were selected and randomly divided into a treatment group and a control group, with 30 patients in each group.

[0044] 2. Diagnostic criteria 2.1 Western Medicine Diagnostic Criteria Based on the "Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition)" and the International Movement Disorders Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease (2015 Edition): (1) Meets the diagnostic criteria for Parkinson's syndrome: bradykinesia (must be present, including difficulty initiating movement, slowed movement, fine motor impairment of the fingers, etc.), and has at least one of the following: resting tremor (4-6Hz), rigidity (cogwheel or lead pipe), or postural and gait disturbance (loss of postural reflexes, erratic gait); (2) Exclude atypical Parkinson's syndromes (such as multiple system atrophy, progressive supranuclear palsy, etc.), secondary Parkinson's syndromes (such as drug-induced, vascular, traumatic, infectious, etc.) and other Parkinson's superimposed syndromes; (3) Supporting criteria: ① Unilateral onset; ② Presence of resting tremor; ③ Progressive worsening of the disease; ④ Good response to levodopa treatment (UPDRS-III improvement rate ≥30% after acute levodopa stress test).

[0045] 2.2 Traditional Chinese Medicine Diagnostic Criteria This study selected relevant standards for tremor syndrome (Yin deficiency and wind stirring syndrome) from the following standards: the "Diagnostic and Efficacy Evaluation Standards for Tremor Syndrome in the Elderly" (1992) issued by the Geriatrics Society of the Chinese Association of Traditional Chinese Medicine, the "National Standard of the People's Republic of China: Terminology of Clinical Diagnosis and Treatment in Traditional Chinese Medicine - Syndrome Section" (2021), and "Traditional Chinese Medicine Diagnostics" (New Century Fifth Edition). The specific standards are as follows: Main symptoms: tremor, unsteady gait, slow movement, dizziness, stiff neck and back, limb spasms, and soreness and weakness in the lower back and knees.

[0046] Secondary symptoms: numbness in the limbs, emaciation, hot flashes in the palms, soles, and chest, night sweats, dry mouth, dry throat, dry eyes, decreased sense of smell, tinnitus, and difficulty in defecation.

[0047] Tongue and pulse: The tongue is red, or the surface is smooth like a mirror, or there are cracks; the pulse is thready and rapid or wiry.

[0048] A diagnosis can be made if the patient presents with any three or more primary symptoms, one or more secondary symptoms, and the tongue and pulse are consistent with the symptoms.

[0049] 2.3 Inclusion Criteria (1) Those who meet the diagnostic criteria for primary PD in Western medicine; and those who also meet the diagnostic criteria for tremor syndrome and yin deficiency with wind syndrome in traditional Chinese medicine; (2) Those who regularly take dopaminergic tablets at a stable dose, or those who do not take the medication; (3) Those aged between 18 and 89 years old; (4) Those who voluntarily accept this study and give informed consent.

[0050] 2.4 Exclusion Criteria (1) Individuals with secondary Parkinson's syndrome or Parkinson's plus syndrome; (2) Patients with other serious internal medicine and surgical diseases; (3) Those who are subjects of other clinical research observations; (4) Those who are currently taking anti-PD Western medicines other than those in this study; and those who are currently using traditional Chinese medicine, proprietary Chinese medicines or acupuncture and other traditional Chinese medicine treatments; (5) Pregnant or lactating women; (6) Other reasons for not being able to accept or complete treatment as required, or poor compliance, and not being able to complete follow-up as required.

[0051] 2.5 Elimination Criteria (1) Those who were found to be ineligible for inclusion after the cases were included; (2) Patients with poor compliance during clinical trials who were unable to cooperate with the trial, or who failed to take medication as required, resulting in treatment interruption; (3) Cases where missing case data leads to biased statistical results; (4) Other serious illnesses that occur during the enrollment period that affect the safety and effectiveness of the trial.

[0052] 2.6 Standards for Detachment and Termination (1) Individuals allergic to the drugs used in this study; (2) Patients who experience severe adverse reactions during treatment and require other treatments; (3) Those whose condition suddenly deteriorates during the study and observation process, or who may experience dangerous emergencies, or who die due to other factors; (4) Those who were lost to follow-up during treatment or who voluntarily withdrew from the trial or were lost to follow-up.

[0053] 2.7 Recording and Management of Adverse Reactions (1) Judgment: Determine whether the changes in the condition after medication are adverse reactions; evaluate the association between the drug and the test drug.

[0054] (2) Records: If it is an adverse reaction, record the cause of its occurrence, clinical symptoms, test and examination results, treatment process, etc.

[0055] (3) Reporting: Adverse events should be reported to the research group within 12 hours; serious adverse reactions should be reported to the supervisor immediately; the research group will ultimately decide whether to terminate the clinical trial.

[0056] (4) Follow-up visits: Follow-up visits will be conducted at 1, 3, 7, 14 and 30 days, depending on the severity of the adverse reaction, to eliminate the adverse effects.

[0057] 3. Treatment methods 3.1 Treatment Group: Patients received the existing stable dose of levodopa / carbidopa tablets orally. For those not currently taking medication, levodopa / carbidopa tablets were administered orally at an initial dose of 1 / 2 tablet, 3 times daily, in addition to the traditional Chinese medicine decoction prepared in Example 1. One dose daily (300ml of decoction obtained from water) was taken twice daily, 150ml each time after breakfast and dinner. Treatment continued for 8 weeks. If a patient's condition worsened during treatment and required adjustment of the Western medicine dosage, this was recorded and included in the compliance set analysis, but patients were not excluded.

[0058] 3.2 Control Group: Patients in the control group received the existing stable dose of levodopa / carbidopa tablets orally. For those not currently taking medication, levodopa / carbidopa tablets were administered orally, starting at 1 / 2 tablet three times daily. No other traditional Chinese medicine or proprietary Chinese medicine for Parkinson's disease was added. The observation period was 8 weeks. If any patient in the control group experienced a worsening of their condition during the observation period requiring adjustment of their Western medicine dosage, this was recorded and included in the compliance set analysis, but they were not excluded.

[0059] Both groups of patients received the same health education during the study, including lifestyle interventions such as guidance on a reasonable diet and suggestions for rehabilitation exercises (walking for 30 minutes or practicing Tai Chi daily).

[0060] 4. Observation Indicators 4.1 Therapeutic Indicators (1) Unified Parkinson's Disease Rating Scale (UPDRS) score: The scores were assessed before treatment, at the end of week 4 and week 8 of treatment. The main observations were the changes in UPDRS-II (Activities of Daily Living, full score 52) and UPDRS-III (Motor Function Test, full score 108).

[0061] (2) Nonmotor Symptom Scale (NMSS) score: The scores were assessed before treatment and at the end of week 8 of treatment. The NMSS assesses nine dimensions: cardiovascular, sleep / fatigue, mood / cognition, perceptual impairment, attention / memory, gastrointestinal, urinary, sexual function, and others. The full score is 360 points, and the higher the score, the more severe the nonmotor symptoms.

[0062] (3) Parkinson's Disease Sleep Scale (PDSS) score: The scores were assessed before treatment and at the end of week 8 of treatment. The PDSS assesses the overall quality of nighttime sleep, difficulty falling asleep, sleep maintenance, dreaming at night, nocturia, limb discomfort, etc. The full score is 150 points, and the higher the score, the better the sleep quality.

[0063] (4) Hamilton Anxiety Rating Scale (HAMA) and Hamilton Depression Rating Scale (HAMD-17) scores: Assessments were conducted before treatment and at the end of week 8 of treatment. A HAMA score ≥14 indicates an anxiety state, and a HAMD-17 score ≥8 indicates a depression state.

[0064] (5) Montreal Cognitive Assessment Scale (MoCA, Beijing version) score: The assessment was conducted before treatment and at the end of week 8 of treatment. The MoCA has a maximum score of 30 points, and a score of ≥26 points indicates normal cognition. The assessment mainly evaluates cognitive domains such as visuospatial / executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation.

[0065] It should be noted that the scales mentioned above in this invention are all mature and standardized assessment scales with fixed items and unified scoring specifications. Therefore, this invention will not elaborate on the specific content of the scales.

[0066] 4.2 Safety Indicators Blood routine tests (WBC, RBC, Hb, PLT), urine routine tests, liver function tests (ALT, AST), and kidney function tests (BUN, Cr) were performed before treatment and at the end of week 8 of treatment. The occurrence time, nature, severity, management measures, and outcomes of adverse events during treatment were recorded. The severity of adverse events was graded according to the Common Adverse Event Evaluation Criteria (CTCAE 5.0).

[0067] 5. Efficacy evaluation criteria The efficacy was evaluated based on the improvement rate of the UPDRS score, as detailed below: Significant effect: Improvement rate of UPDRS total score (UPDRS-Ⅰ+Ⅱ+Ⅲ, in this observation it is calculated as Ⅱ+Ⅲ) ≥30%; Effective: Improvement rate of UPDRS total score ≥15% and <30%; Ineffective: UPDRS total score improvement rate <15%.

[0068] UPDRS total score improvement rate (%) = (total score before treatment - total score after treatment) / total score before treatment × 100%.

[0069] Overall effectiveness rate = (number of cases with significant effect + number of cases with effective effect) / total number of cases × 100%.

[0070] 6. Statistical methods All data were analyzed using SPSS 26.0 statistical software. Quantitative data are expressed as mean ± standard deviation (SD). The data are categorized as follows: If the data follows a normal distribution with homogeneous variances, paired t-tests are used for comparisons within a group before and after treatment, and independent samples t-tests are used for comparisons between groups; if the data does not follow a normal distribution, the Wilcoxon rank-sum test is used. Count data are expressed as percentages (%) and analyzed using the χ² test or Fisher's exact test. A p-value < 0.05 is considered statistically significant.

[0071] 7. Treatment Results 7.1 Completion status of the two groups of cases Of the 30 patients in the treatment group, 26 completed all 8 weeks of treatment and assessment. Two patients withdrew in week 6 due to personal reasons (family relocation), one withdrew in week 4 due to mild abdominal distension (CTCAE grade 1), and one withdrew due to personal reasons. A total of 26 patients ultimately completed the treatment. Of the 30 patients in the control group, 27 completed all 8 weeks of observation and assessment. One patient withdrew in week 4 due to self-administering other traditional Chinese medicine, one withdrew in week 5 due to hospitalization and treatment plan adjustments caused by worsening condition, and one withdrew due to personal reasons. A total of 27 patients ultimately completed the treatment. The following efficacy analysis is based on the protocol set (those who completed all treatment and assessment), namely, the 26 patients in the treatment group and the 27 patients in the control group.

[0072] Before treatment, among the 26 patients in the treatment group, there were 15 males and 11 females, aged 55 to 78 years, with a mean age of (67.2±6.8) years and a disease duration of 1 to 10 years, with a mean duration of (5.6±3.2) years. According to the Hoehn-Yahr stage, there were 5 cases (19.23%) in stage 1, 8 cases (30.77%) in stage 1.5, 6 cases (23.08%) in stage 2, 5 cases (19.23%) in stage 2.5, and 2 cases (7.69%) in stage 3. The control group consisted of 27 patients, including 14 males and 13 females, aged 54–79 years (mean 66.8 ± 7.1 years), with a disease duration of 1.5–11 years (mean 5.8 ± 3.5 years). Hoehn-Yahr staging was as follows: stage 1 (5 cases, 18.52%), stage 1.5 (8 cases, 29.63%), stage 2 (7 cases, 25.93%), stage 2.5 (5 cases, 18.52%), and stage 3 (2 cases, 7.41%). There were no statistically significant differences between the two groups in general characteristics such as gender, age, disease duration, Hoehn-Yahr staging, and baseline total UPDRS score (P > 0.05), indicating comparability.

[0073] 7.2 Comparison of overall therapeutic effects between the two groups At the end of week 8 of treatment, in the treatment group, 6 cases (23.08%) showed significant improvement, 17 cases (65.38%) showed improvement, and 3 cases (11.54%) showed no improvement, with a total effective rate of 88.46%. In the control group, 1 case (3.70%) showed significant improvement, 12 cases (44.44%) showed improvement, and 14 cases (51.85%) showed no improvement, with a total effective rate of 48.15%. The comparison of the total effective rates between the two groups was statistically significant (χ²=10.05, P<0.01). The results are shown in Table 1.

[0074] Table 1 Comparison of overall therapeutic effects between the two groups [n(%)] control group 27 1 12 14 48.15% Treatment group 26 6 17 3 <![CDATA[88.46% △ ]]> Note: Compared with the control group, △ P<0.01.

[0075] 7.3 Comparison of UPDRS scores before and after treatment in the two groups Before treatment, there were no statistically significant differences in UPDRS-II, UPDRS-III, and total UPDRS scores between the two groups (P>0.05). At the end of week 8 of treatment, the treatment group showed a significant decrease in UPDRS-II, UPDRS-III, and total UPDRS scores compared to pre-treatment levels (P<0.01); the control group showed a slight decrease in UPDRS-II, UPDRS-III, and total UPDRS scores compared to pre-treatment levels, with a statistically significant decrease in UPDRS-III (P<0.05), but no statistically significant decrease in UPDRS-II or total scores (P>0.05). After treatment, there were statistically significant differences in UPDRS-II, UPDRS-III, and total scores between the two groups (P<0.05 or P<0.01). The results are shown in Table 2.

[0076] Table 2 Comparison of UPDRS scores before and after treatment in the two groups (points, ) Treatment group 26 Before treatment 14.23±5.67 28.67±9.34 42.90±13.58 Treatment group 26 After treatment <![CDATA[8.92±4.15 aa,bb ]]> <![CDATA[18.77±7.23 aa,bb ]]> <![CDATA[27.69±9.86 aa,bb ]]> control group 27 Before treatment 13.97±5.43 27.93±9.67 41.90±13.48 control group 27 After treatment 12.96±5.18 <![CDATA[25.00±8.72 a ]]> 37.96±12.18 Note: Compared with the pre-treatment level in this group. a P<0.05; compared with before treatment in this group, aa P<0.01; compared with the control group after treatment, bb P<0.01.

[0077] 7.4 Comparison of scores on non-motor symptom-related scales between the two groups Before treatment, there were no statistically significant differences in NMSS, PDSS, HAMA, and HAMD-17 scores between the two groups (P>0.05). At the end of week 8 of treatment, the NMSS, HAMA, and HAMD-17 scores in the treatment group were significantly lower than before treatment (P<0.01), while the PDSS score was significantly higher (P<0.01). In the control group, there were no significant changes in any of the scores compared to before treatment (P>0.05). After treatment, there were statistically significant differences in all scores between the two groups (P<0.01). The results are shown in Table 3.

[0078] Table 3 Comparison of non-motor symptom-related scale scores before and after treatment in the two groups (points, ) Treatment group 26 Before treatment 52.37±18.46 89.67±18.34 16.37±5.24 18.43±6.12 Treatment group 26 After treatment <![CDATA[25.88±13.67 aa,bb ]]> <![CDATA[120.73±16.88 aa,bb ]]> <![CDATA[8.73±3.96 aa,bb ]]> <![CDATA[9.88±4.52 aa,bb ]]> control group 27 Before treatment 50.97±17.82 88.33±17.65 15.97±5.03 17.97±5.87 control group 27 After treatment 49.04±16.58 90.47±16.89 14.89±5.01 16.85±5.42 Note: Compared with the pre-treatment level in this group. aa P<0.01; compared with the control group after treatment, bb P<0.01. NMSS: Nonmotor Symptom Scale, higher scores indicate more severe nonmotor symptoms; PDSS: Parkinson's Disease Sleep Scale, higher scores indicate better sleep quality; HAMA: Hamilton Anxiety Rating Scale; HAMD-17: Hamilton Depression Rating Scale.

[0079] 7.5 Comparison of non-motor symptom improvement rates between the two groups The NMSS reduction rate (pre-treatment score - post-treatment score) / pre-treatment score × 100% was used as the overall improvement indicator for non-motor symptoms. A reduction rate of ≥50% was considered significant, ≥20% and <50% was considered effective, and <20% was considered ineffective. The improvement of non-motor symptoms in the two groups was statistically analyzed.

[0080] At the end of week 8 of treatment, in the treatment group, 14 cases (53.85%) showed significant improvement in non-motor symptoms, 10 cases (38.46%) showed improvement, and 2 cases (7.69%) showed no improvement, with a total improvement rate of 92.31%. In the control group, 2 cases (7.41%) showed significant improvement in non-motor symptoms, 9 cases (33.33%) showed improvement, and 16 cases (59.26%) showed no improvement, with a total improvement rate of 40.74%. The comparison of the total improvement rate of non-motor symptoms between the two groups was statistically significant (χ²=15.44, P<0.01). The results are shown in Table 4.

[0081] Table 4 Comparison of improvement in non-motor symptoms (NMSS score reduction rate) between the two groups [n(%)] Treatment group 26 14（53.85） 10（38.46） 2（7.69） <![CDATA[24(92.31) △ ]]> control group 27 2（7.41） 9（33.33） 16（59.26） 11（40.74） Note: Compared with the control group, △ P<0.01.

[0082] 7.6 Comparison of MoCA scores before and after treatment in the two groups Before treatment, there was no statistically significant difference in MoCA scores between the two groups (P>0.05). At the end of week 8 of treatment, the MoCA score in the treatment group increased slightly compared to before treatment, but the difference was not statistically significant (P>0.05); the MoCA score in the control group did not change significantly compared to before treatment (P>0.05). There was also no statistically significant difference in MoCA scores between the two groups after treatment (P>0.05). The results are shown in Table 5.

[0083] Table 5 Comparison of MoCA scores before and after treatment in the two groups (points, ) Treatment group 26 24.13±3.42 25.58±3.37 control group 27 24.67±3.15 24.33±3.42 7.7 Safety Evaluation During treatment, one patient in the treatment group withdrew in week 4 due to mild abdominal distension (CTCAE grade 1). It was impossible to determine whether this adverse reaction was related to the traditional Chinese medicine decoction; it was mild and resolved spontaneously without specific treatment. Among the remaining patients in the treatment group who completed treatment, one experienced transient mild diarrhea (2-3 loose stools daily) in week 2. After being instructed to take the medication one hour after meals, the symptoms disappeared within 3 days and did not affect continued treatment. Another patient experienced dry throat discomfort in week 5, which was relieved after drinking adequate water. In the control group, one patient experienced mild nausea (CTCAE grade 1), which resolved spontaneously without specific treatment; and one patient experienced worsening constipation in week 6, which improved after dietary guidance.

[0084] No clinically significant abnormalities were observed in blood routine tests, urine routine tests, liver function (ALT, AST), and kidney function (BUN, Cr) before and after treatment in either group, and there were no statistically significant differences between the groups (P>0.05). No serious adverse events occurred in either group.

[0085] 8. Clinical trial conclusions This clinical observation preliminarily shows that, on the basis of conventional anti-Parkinson's disease Western medicine treatment, the addition of the traditional Chinese medicine decoction of Example 1 of this invention resulted in a total effective rate of 88.46% in the treatment group after 8 weeks of treatment, which was significantly higher than 48.15% in the control group (P<0.01). This suggests that the traditional Chinese medicine composition of this invention can significantly improve the motor symptoms of Parkinson's disease patients (UPDRS-II and UPDRS-III scores are significantly reduced). Regarding non-motor symptoms, the NMSS score in the treatment group decreased from 52.37±18.46 before treatment to 25.88±13.67 (P<0.01), and the total improvement rate of non-motor symptoms, calculated by the NMSS reduction rate, reached 92.31%, which was significantly better than the 40.74% in the control group (P<0.01). The PDSS score increased from 89.67±18.34 to 120.73±16.88 (P<0.01), the HAMA score decreased from 16.37±5.24 to 8.73±3.96 (P<0.01), and the HAMD-17 score decreased from 18.43±6.12 to 9.88±4.52 (P<0.01), suggesting that this formula has a particularly prominent effect on improving non-motor symptoms such as sleep disorders, anxiety, and depression in Parkinson's disease patients. In terms of safety, no obvious adverse reactions were observed in the traditional Chinese medicine group, and no serious adverse reactions such as liver and kidney damage were observed, suggesting that the formula has good safety and is suitable for long-term use.

[0086] Typical case: Case 1: Yin deficiency with yang excess and significant wind-related symptoms.

[0087] Mr. Liu, male, 65 years old, first visit on March 12, 2025.

[0088] Chief complaint: Involuntary tremors of the right limbs for 3 years, which have worsened and have been accompanied by dizziness and tinnitus for 2 months.

[0089] Present Illness: Three years ago, the patient developed involuntary tremors in the right upper limb without any obvious cause. The tremors resembled pill-rolling movements, were more pronounced at rest, and worsened during periods of mental stress or emotional excitement, as well as during periods of concentration. They completely disappeared during sleep. Over the past two years, tremors gradually developed in the right lower limb, causing dragging of the right leg when walking, difficulty initiating initiation, and requiring 3-4 steps to turn. In April 2023, the patient consulted a neurologist at the local municipal hospital and was diagnosed with Parkinson's disease. The patient was prescribed levodopa / carbidopa tablets (125mg three times daily). The tremors began to lessen approximately 40 minutes after administration, but returned after about 3 hours, becoming significantly more severe after the medication wore off. In the past two months, the amplitude and frequency of the tremors have significantly increased, accompanied by dizziness, tinnitus, a feeling of being on a boat, irritability, frequent arguments with family members, difficulty falling asleep at night (requiring 1-2 hours to fall asleep), frequent awakenings (3-4 times per night), and difficulty falling back asleep. The patient has a 5-year history of hypertension, and has been taking nifedipine controlled-release tablets 30mg once daily, with blood pressure controlled at 130-140 / 80-88 mmHg. The patient denies a history of smoking and occasionally drinks alcohol (in small amounts during social occasions).

[0090] Current symptoms: Moderate-amplitude resting tremor in the right limbs, with a frequency of approximately 5 Hz, which worsens when holding a cup in the right hand; difficulty writing (significantly smaller and trembling handwriting); increased muscle tone in the right limbs (cogwheel rigidity); dragging gait in the right lower limb, difficulty initiating movement, and slow turning. Dizziness and tinnitus; irritability; dry mouth and throat; thirst with a preference for cold drinks; constipation (bowel-shaped stools every 2-3 days). Good appetite and frequent urination. Red tongue with little coating; thin tongue body; wiry, thready, and rapid pulse.

[0091] Specialist examination: Hoehn-Yahr stage 2.5. UPDRS-II score 11, UPDRS-III score 32, total score 43. HAMA score 18, HAMD-17 score 14, PDSS score 78, MoCA score 25.

[0092] Western medicine diagnosis: Parkinson's disease (stage 2.5). Traditional Chinese medicine diagnosis: Tremor syndrome (Yin deficiency and Yang excess, with significant wind movement).

[0093] Prescription: The formula used in Example 2 is as follows: Rehmannia glutinosa 25g, turtle shell 20g (decocted first), Gastrodia elata 12g, pearl powder 25g (decocted first), Ligustrum lucidum 15g, Eclipta prostrata 15g, Acanthopanax senticosus 10g, Curcuma longa 6g, Polygonum multiflorum vine 15g, Acorus tatarinowii 3g, Polygala tenuifolia 6g. One dose per day, decocted in water to obtain 300ml of liquid, taken warm twice a day after breakfast and dinner. Turtle shell and pearl powder should be decocted for 20 minutes before adding the remaining herbs. The original dopaminergic tablet regimen remains unchanged (125mg each time, 3 times a day). Patients are instructed to keep a medication diary, including the time of medication, changes in symptoms, and adverse reactions.

[0094] Second visit (March 26, 2025, after 14 doses): The patient reported that the tremor amplitude decreased from the 5th day of medication, and the dizziness and tinnitus were significantly relieved after the 10th day. Currently, the tremor when holding a cup with the right hand is less pronounced, food spillage is reduced, and handwriting is neater. Irritability has improved (only one argument with family members this week). Sleep duration has increased to approximately 5-6 hours per night, and the time to fall asleep has shortened to 30-40 minutes. Dry mouth has lessened, and bowel movements occur every 1-2 days, with soft, formed stools. Tongue is red with a thin, sparse coating, and pulse is wiry and thready. UPDRS-III score is 26. The prescription remains unchanged; continue for another 14 doses, using the same method as before. The patient is instructed to keep a medication diary.

[0095] Third visit (April 9, 2025, after 28 doses of medication): The patient's tremors were significantly reduced; holding a cup with the right hand was basically stable; writing was legible; food spillage decreased by approximately 70% compared to before. Movements were more agile than before, with smooth initiation and a two-step turn. Dizziness and tinnitus had largely disappeared; mood was stable; and relationships with family members had improved. Sleep reached 6-7 hours, with 1-2 awakenings at night but able to fall back asleep. Dry mouth disappeared; bowel movements occurred once daily. Tongue was pale red with a thin white coating; pulse was wiry and thready. UPDRS-III score was 19 (40.6% improvement from pre-treatment), HAMA score was 11, HAMD-17 score was 9, PDSS score was 112, and MoCA score was 26. The improvement rate of the total UPDRS score after 28 days of treatment was (43-28) / 43×100%=34.9%, which was rated as "effective" according to the efficacy evaluation criteria. The prescription was adjusted to the ratio in Example 1 (20g Rehmannia glutinosa, 15g turtle shell, 10g Gastrodia elata, 20g pearl powder, with the remaining herbs as before), and continued for 14 doses to consolidate the therapeutic effect. At the same time, the patient was instructed to gradually increase rehabilitation exercises, including brisk walking for 30 minutes daily and practicing basic Tai Chi skills.

[0096] Follow-up: A telephone follow-up was conducted 3 months after the end of treatment. The patient reported that the tremor was well controlled, and the ability to take care of oneself had significantly improved. The patient could perform daily activities such as dressing, eating, and washing independently, and had resumed the habit of daily morning exercise. No adverse reactions were observed. The dosage of the Western medicine DOPA tablets was maintained at the original level and was not increased.

[0097] Case 2: Yin deficiency with wind stirring, combined with phlegm and blood stasis obstructing the collaterals and mental disturbance.

[0098] Ms. Wang, female, 68 years old, retired accountant, first visit on June 8, 2025.

[0099] Chief complaint: Stiffness and slow movement for 5 years, which has worsened and been accompanied by insomnia and forgetfulness for 6 months.

[0100] Present Illness: Five years ago (early 2020), the patient gradually developed stiffness in the left limbs without any obvious cause, mainly in the left shoulder and left upper limb. Fine motor skills such as dressing and buttoning clothes became difficult. When walking, the left lower limb dragged, the stride became shorter, and a hurried gait was observed. Facial expressions gradually decreased (family members described the patient as "expressionless"). In June 2021, the patient consulted a neurologist at a provincial hospital and was diagnosed with Parkinson's disease. The patient was prescribed levodopa / carbidopa tablets (125mg three times daily). The stiffness in the limbs lessened and mobility improved approximately one hour after taking the medication, but the effect lasted for about 3.5 hours before diminishing. In the past six months, the condition has gradually worsened, with significant stiffness in the limbs, difficulty flexing and extending the left lower limb, requiring 2-3 attempts to take the first step, and "frozen gait" occurring 2-3 times per week. The patient also experiences insomnia (total sleep time of approximately 2-3 hours per night, difficulty falling asleep, and waking up 4-5 times during the night), significant forgetfulness (frequently forgetting to turn off the stove while cooking, forgetting to bring keys when going out, and forgetting the names of familiar people), low mood, reluctance to communicate with others, occasional urge to cry, and a feeling that "life is meaningless" but without suicidal thoughts. Bowel movements are constipated (once every 3-4 days, requiring the use of enemas). The patient has an 8-year history of type 2 diabetes, taking metformin extended-release tablets 0.5g twice daily, with relatively good blood sugar control (fasting blood glucose 6.5-7.5 mmol / L, 2-hour postprandial blood glucose 9-11 mmol / L). The patient is introverted and has no history of smoking or drinking alcohol.

[0101] Current symptoms: Significant stiffness in the limbs, predominantly on the left side, with limited flexion and extension; loss of arm swing in the left upper limb; dragging gait in the left lower limb; difficulty initiating movement; turning requires 4-5 steps; blank facial expression; reduced blinking. Insomnia at night, difficulty falling asleep (1.5-2 hours), frequent awakenings (4-5 times / night), and difficulty falling back asleep after waking. Significant forgetfulness, recent memory decline, with a MoCA score of only 1 out of 5 for delayed recall. Depressed mood, decreased interest, HAMD-17 score ≥ 20. Constipation, bowel movements every 3-4 days. Dark red tongue with scattered petechiae on the edges; slightly swollen tongue body; thin, greasy, slightly yellow coating; wiry and hesitant pulse.

[0102] Specialist examination: Hoehn-Yahr stage 3. UPDRS-II score: 15, UPDRS-III score: 38, total score: 53. NMSS score: 65, PDSS score: 68, HAMA score: 16, HAMD-17 score: 22, MoCA score: 22 (mild cognitive impairment).

[0103] Western medicine diagnosis: Parkinson's disease (stage 3) with mild cognitive impairment, anxiety and depression. Traditional Chinese medicine diagnosis: Tremor syndrome (Yin deficiency with wind stirring, phlegm and blood stasis obstructing the collaterals, and mental disturbance).

[0104] Prescription: The formula used in Example 3 is as follows, with the actual dosage as follows: Rehmannia glutinosa 15g, turtle shell 10g (decocted first), Gastrodia elata 9g, pearl powder 15g (decocted first), Ligustrum lucidum 10g, Eclipta prostrata 10g, Acanthopanax senticosus 20g, Curcuma longa 15g, Polygonum multiflorum vine 30g, Acorus tatarinowii 10g, Polygala tenuifolia 12g. One dose per day, decocted in water to obtain 300ml of liquid, taken warm twice a day after breakfast and dinner. Turtle shell and pearl powder should be decocted for 20 minutes before adding the remaining herbs. The original dopaminergic tablet regimen remains unchanged (125mg each time, 3 times a day). The patient's family is also instructed to assist in keeping a daily sleep diary and medication diary.

[0105] Second visit (June 22, 2025, after 14 doses): The patient reported that nighttime sleep duration increased after the 3rd day of medication, and after the 7th day, he could sleep continuously for 4-5 hours. Limb stiffness was reduced, and the left lower limb flexion and extension were more flexible than before; difficulty initiating movement improved (frozen gait decreased to 1-2 times per week). Forgetfulness improved slightly (family reported he could remember the time of medication administration). Mood was more stable than before, and he actively communicated with others more frequently. Bowel movements occurred every 2-3 days, but still required assisted bowel movements. Tongue was dark red, with fewer petechiae than before, thin white coating, and a wiry, hesitant pulse. UPDRS-III score was 32 (improvement rate 15.8%), and PDSS score was 98. The prescription was maintained for another 14 doses, using the same method as before. The patient's family was instructed to accompany him for a 20-minute outdoor walk daily.

[0106] Third visit (July 6, 2025, after 28 doses of medication): The patient's stiffness was significantly reduced; the left upper limb could button its clothes; the dragging motion of the left lower limb was significantly improved; stride length was increased, and the patient could take one or two steps to start a movement and complete a turn in three steps; facial expressions were more expressive than before. Sleep duration increased to approximately 5-6 hours per night, and the time to fall asleep was shortened to 30-45 minutes; the patient woke up 2-3 times during the night but could fall back asleep quickly. Forgetfulness significantly improved; the patient could remember daily medications and key instructions such as turning off the stove. The patient's mood was stable, and the patient was willing to participate in community activities for the elderly. Bowel movements occurred once every 1-2 days, with occasional need for defecation. The tongue was pale red, with petechiae largely disappeared, a thin white coating, and a wiry pulse. UPDRS-III score was 23 (39.5% improvement from pre-treatment), NMSS score was 42, PDSS score was 126, HAMA score was 10, HAMD-17 score was 11, and MoCA score was 27. After 28 days of treatment, the improvement rate of the total UPDRS score was (53-34) / 53×100%=35.8%, which was rated as "effective" according to the efficacy evaluation criteria; the improvement rate of NMSS was (65-42) / 65×100%=35.4%. The prescription was adjusted to a transitional prescription: Rehmannia glutinosa 20g, turtle shell 15g (decocted first), Gastrodia elata 10g, pearl powder 20g (decocted first), Acanthopanax senticosus 15g, Curcuma longa 10g, Polygonum multiflorum vine 25g, Acorus tatarinowii 8g, Polygala tenuifolia 10g, Ligustrum lucidum 15g, Eclipta prostrata 15g, and continued for 14 doses to consolidate the therapeutic effect. The patient was instructed to continue daily walking and cognitive training.

[0107] Fourth visit (August 3, 2025, after 42 doses of medication, followed by a one-week break): The patient's limb mobility has significantly improved compared to before, and they are basically self-sufficient in daily life, able to independently complete daily activities such as dressing, washing, and cooking. Sleep is good (6-7 hours per night, waking 1-2 times), cognitive function has basically returned to normal (MoCA score 28), mood is stable, and they have returned to community square dancing activities (gentle movements). UPDRS-III score is 20, an improvement rate of 47.4% compared to before treatment. The total UPDRS score improvement rate is (53-31) / 53×100%=41.5%. Follow-up liver and kidney function tests are normal.

[0108] Follow-up: At a 6-month outpatient follow-up after treatment, the patient's gait was stable, with occasional episodes of frozen gait (approximately 1-2 times per month). Sleep was good, with a MoCA score of 27 and a HAMD-17 score of 9. The original dopaminergic regimen was maintained without dosage increase, and no adverse reactions occurred. The patient and family expressed satisfaction with the treatment outcome.

[0109] Case 3: Yin deficiency with wind stirring and prominent insomnia.

[0110] Ms. Zhao, female, 62 years old, retired worker, first visit on September 15, 2025.

[0111] Chief complaint: Tremors in both hands for 4 years, worsening and accompanied by severe insomnia for 1 year.

[0112] Present Illness: Four years ago, the patient developed fine tremors in both hands without any obvious cause. Initially, she did not pay much attention to it, but it gradually worsened, affecting her daily life (dropping food while holding chopsticks, and writing with shaky hands). In 2022, she was diagnosed with Parkinson's disease at a local hospital and was prescribed levodopa / carbidopa tablets (125mg each time, three times a day), which provided some relief. In the past year, the tremors have worsened, and she has developed severe insomnia, only able to sleep for 1-2 hours each night, or even not sleeping at all. She has tried taking estazolam 1mg before bedtime, but the effect was not ideal. She also experiences irritability, palpitations, hot flashes, sweating, and dry mouth. She has been healthy previously and has been menopausal for 12 years. She has a generally irritable personality and has been retired and living at home with little physical activity.

[0113] Current symptoms: Significant resting tremor in both hands, moderate to large amplitude, worsening to the point of inability to hold objects with slight emotional excitement. Movement is still possible, without significant rigidity or gait disturbance. Severe insomnia (1-2 hours per night), irritability, palpitations, easily startled, hot flashes and sweating (3-5 times daily), dry mouth with a desire to drink. Constipation (once every 2 days). Red tongue with little moisture, thin yellow coating, thready and rapid pulse.

[0114] Specialist examination: Hoehn-Yahr stage 2. UPDRS-II score: 8, UPDRS-III score: 28, total score: 36. PDSS score: 52, HAMA score: 21, HAMD-17 score: 16, MoCA score: 26.

[0115] Western medicine diagnosis: Parkinson's disease (stage 2) with anxiety and severe sleep disturbance. Traditional Chinese medicine diagnosis: Tremor syndrome (Yin deficiency with wind stirring, restlessness of mind).

[0116] Prescription: The formula used is the same as in Example 4, specifically as follows: 20g Rehmannia glutinosa, 15g Carapax Trionycis, 12g Gastrodia elata, 30g Pearl powder, 15g Ligustrum lucidum, 15g Eclipta prostrata, 15g Acanthopanax senticosus, 10g Curcuma longa, 30g Polygonum multiflorum vine, 6g Acorus tatarinowii, 12g Polygala tenuifolia. One dose daily, decocted in water to obtain 300ml of liquid, taken warm twice daily, morning and evening after meals. The existing dopaminergic alachlor tablet regimen remains unchanged (125mg each time, three times daily). Estazolam is discontinued.

[0117] Second visit (September 29, 2025, after 14 doses): The patient's sleep has significantly improved, sleeping 5-6 hours per night, with the time to fall asleep shortened to within 30 minutes. The patient wakes 1-2 times during the night but can fall back asleep. Tremors have lessened, irritability and palpitations have improved, and hot flashes and sweating have decreased (1-2 times daily). Dry mouth has lessened. The tongue is red with a thin white coating, and the pulse is thready. The UPDRS-III score is 21 (improvement rate 25.0%). The prescription remains unchanged; continue for another 14 doses.

[0118] Third visit (October 13, 2025, after 28 doses of medication): Sleep is basically normal (6-7 hours per night), tremors have significantly decreased (food is barely dropped when holding chopsticks), mood is stable, hot flashes and sweating occur occasionally (1-2 times per week), dry mouth has disappeared. Tongue is pale red with a thin white coating, pulse is thready. UPDRS-III score is 17 (39.3% improvement compared to before treatment), UPDRS total score is (36-23) / 36×100%=36.1%, rated as "significantly effective". The prescription is adjusted, the dose of Polygonum multiflorum vine is reduced to 20g, the rest of the medicine remains the same. Continue taking 14 doses for consolidation.

[0119] Follow-up: At a 3-month follow-up after treatment, the patient slept well (6-7 hours per night), tremor was satisfactorily controlled, and quality of life had significantly improved. The original dose of levodopa / carbidopa tablets was maintained. No adverse reactions were observed.

[0120] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating Parkinson's disease with yin deficiency and wind-stirring syndrome, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15-30 parts of Rehmannia glutinosa, 10-25 parts of turtle shell, 6-15 parts of Gastrodia elata, 15-30 parts of pearl powder, 10-20 parts of Ligustrum lucidum, 10-20 parts of Eclipta prostrata, 10-20 parts of Acanthopanax senticosus, 6-15 parts of Curcuma longa, 15-30 parts of Polygonum multiflorum vine, 3-10 parts of Acorus tatarinowii, and 6-12 parts of Polygala tenuifolia.

2. The traditional Chinese medicine composition for treating Parkinson's disease with yin deficiency and wind-stirring syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 25-30 parts of Rehmannia glutinosa, 20-25 parts of turtle shell, 12-15 parts of Gastrodia elata, 25-30 parts of pearl powder, 15-20 parts of Ligustrum lucidum, 15-20 parts of Eclipta prostrata, 10-15 parts of Acanthopanax senticosus, 6-10 parts of Curcuma longa, 15-20 parts of Polygonum multiflorum vine, 3-6 parts of Acorus tatarinowii, and 6-9 parts of Polygala tenuifolia.

3. The traditional Chinese medicine composition for treating Parkinson's disease with yin deficiency and wind-stirring syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15-20 parts of Rehmannia glutinosa, 10-15 parts of turtle shell, 9-12 parts of Gastrodia elata, 15-20 parts of pearl powder, 10-15 parts of Ligustrum lucidum, 10-15 parts of Eclipta prostrata, 15-20 parts of Acanthopanax senticosus, 10-15 parts of Curcuma longa, 25-30 parts of Polygonum multiflorum vine, 6-10 parts of Acorus tatarinowii, and 9-12 parts of Polygala tenuifolia.

4. The traditional Chinese medicine composition for treating Parkinson's disease with yin deficiency and wind-stirring syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 20 parts Rehmannia glutinosa, 15 parts turtle shell, 10 parts Gastrodia elata, 20 parts pearl powder, 15 parts Ligustrum lucidum, 15 parts Eclipta prostrata, 15 parts Acanthopanax senticosus, 10 parts Curcuma longa, 20 parts Polygonum multiflorum vine, 6 parts Acorus tatarinowii, and 10 parts Polygala tenuifolia.

5. The traditional Chinese medicine composition for treating Parkinson's disease with yin deficiency and wind-stirring syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 20 parts Rehmannia glutinosa, 15 parts turtle shell, 12 parts Gastrodia elata, 30 parts pearl powder, 15 parts Ligustrum lucidum, 15 parts Eclipta prostrata, 15 parts Acanthopanax senticosus, 10 parts Curcuma longa, 30 parts Polygonum multiflorum vine, 6 parts Acorus tatarinowii, and 12 parts Polygala tenuifolia.

6. A traditional Chinese medicine preparation for treating Parkinson's disease with Yin deficiency and wind-stirring syndrome, characterized in that, The traditional Chinese medicine preparation is any one of decoction, granules, tablets, pills, capsules, powders, and oral liquids, and is prepared using the traditional Chinese medicine composition described in any one of claims 1 to 5.

7. A traditional Chinese medicine preparation for treating Parkinson's disease with yin deficiency and wind-stirring syndrome according to claim 6, characterized in that, The traditional Chinese medicine preparation is a decoction. The preparation method of the decoction includes the following steps: Clean and select the medicinal materials for later use; crush the turtle shell and mother-of-pearl, put them into a clay pot, add cold water, and decoct for 15-30 minutes; then add the remaining medicinal materials to the clay pot that was decocted first, add cold water to cover the medicinal materials, bring to a boil over high heat, then reduce to a simmer and decoct for 40-60 minutes. Pour out the first decoction, filter it with two layers of gauze, and store it in a clean container; for the second decoction, add warm water to the dregs to cover them, bring to a boil over high heat, then reduce to a simmer and decoct for 30-40 minutes. Filter the decoction, and mix the filtered decoction with the first decoction.