A traditional Chinese medicine composition for treating cerebellar ataxia syndrome, a preparation method, a pharmaceutical preparation and applications

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, preparation method, pharmaceutical formulation, and application for treating cerebellar ataxia syndrome. The composition comprises the following components: Rehmannia glutinosa (raw and processed), Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium nobile, Curculigo orchioides, Panax ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus tatarinowii, Angelica dahurica, Poria cocos, Schisandra chinensis, Citrus reticulata peel, and Amomum villosum. The preparation method involves first soaking Rehmannia glutinosa (raw and processed) to obtain mixture A; then mixing the remaining ingredients and soaking them in water to obtain mixture B; finally, combining mixture A and mixture B, and decocting to obtain the final product. This traditional Chinese medicine formula can treat cerebellar ataxia syndrome, improving the main symptoms of ataxia such as gait instability, balance disorders, and dysarthria; it also helps to resolve turbidity and improve secondary symptoms such as bowel and bladder dysfunction, sleep disorders, and mental disorders, promoting patient compliance, slowing and stabilizing disease progression, and improving patients' quality of life.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, preparation method, pharmaceutical formulation and application for treating cerebellar ataxia syndrome. Background Technology

[0002] Cerebellar ataxia syndromes are a group of chronic, progressive neurodegenerative diseases characterized by cerebellar dysfunction or combined with other neurological abnormalities. Clinical manifestations include gait abnormalities, impaired balance, poor limb coordination, and speech disorders. The disease progresses, leading to loss of walking ability in the middle and late stages and ultimately death. Once onset, the disease course is irreversible, severely impacting patients' quality of life and placing a significant burden on the social healthcare system. The mechanisms of cerebellar ataxia are complex, with diverse etiologies. Most cases are autosomal dominant, a few are autosomal recessive, and some are sporadic. Currently, there are no effective drugs that can halt or slow disease progression as routine treatments; only medications can temporarily alleviate ataxia symptoms.

[0003] Currently, most drugs for treating cerebellar ataxia syndrome are still in clinical trials. However, most of them can only improve the main symptoms of some types of ataxia, with limited efficacy and no effect on the secondary symptoms of the syndrome. Traditional Chinese medicine formulas have limitations such as poor targeted symptom efficacy, unstable efficacy, and difficulty in application, resulting in poor medication adherence for some patients and failing to achieve the effect of delaying and stabilizing the progression of the disease. Summary of the Invention

[0004] To address the problems existing in the prior art, this invention provides a traditional Chinese medicine composition, preparation method, and application for treating cerebellar ataxia syndrome.

[0005] To achieve the purpose of the invention, the following technical solution is adopted:

[0006] A traditional Chinese medicine composition for treating cerebellar ataxia syndrome comprises the following components: Rehmannia glutinosa (raw), Rehmannia glutinosa (processed), Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium nobile, Curculigo orchioides, Panax ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus tatarinowii, Angelica dahurica, Poria cocos, Schisandra chinensis, Citrus reticulata peel, and Amomum villosum.

[0007] Preferably, by weight, it comprises the following components: 20-50 parts of raw Rehmannia glutinosa, 30-100 parts of prepared Rehmannia glutinosa, 15-30 parts of Cistanche deserticola, 15-30 parts of Morinda officinalis, 15-30 parts of Cornus officinalis, 10-15 parts of Dendrobium nobile, 10-20 parts of Curculigo orchioides, 5-10 parts of Panax ginseng, 6-9 parts of Ophiopogon japonicus, 5-10 parts of Polygala tenuifolia, 6-12 parts of Acorus tatarinowii, 6-15 parts of Angelica dahurica, 15-30 parts of Poria cocos, 6-15 parts of Schisandra chinensis, 10-15 parts of Citrus reticulata peel, and 5-10 parts of Amomum villosum.

[0008] Preferably, the Polygala tenuifolia is prepared Polygala tenuifolia, and the composition further includes 30-100 parts by weight of rice wine.

[0009] Preferably, by weight, it comprises the following components: 50 parts raw Rehmannia glutinosa, 50 parts prepared Rehmannia glutinosa, 30 parts Cistanche deserticola, 30 parts Morinda officinalis, 30 parts Cornus officinalis, 15 parts Dendrobium nobile, 10 parts Curculigo orchioides, 10 parts ginseng, 9 parts Ophiopogon japonicus, 10 parts prepared Polygala tenuifolia, 12 parts Acorus tatarinowii, 12 parts Angelica dahurica, 15 parts Poria cocos, 10 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 10 parts Amomum villosum.

[0010] A second objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0011] (1) Soak raw and processed Rehmannia glutinosa in a solvent to obtain mixture A;

[0012] (2) Mix Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium nobile, Curculigo orchioides, Panax ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus tatarinowii, Angelica dahurica, Poria cocos, Schisandra chinensis, Citrus reticulata and Amomum villosum, and soak in water to obtain mixture B;

[0013] (3) Combine mixture A and mixture B, boil them together, and collect the decoction to obtain the final product.

[0014] Preferably, the solvent in step (1) is rice wine, and the soaking time is 10-50 minutes.

[0015] Preferably, the amount of water used in step (2) is: Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium nobile, Curculigo orchioides, and Panax ginseng.

[0016] The total mass of Ophiopogon japonicus, Polygala tenuifolia, Acorus tatarinowii, Angelica dahurica, Poria cocos, Schisandra chinensis, Citrus reticulata peel, and Amomum villosum is 2-8 times, and the soaking time is 10-40 minutes.

[0017] Preferably, in step (3), the decoction is performed 1-3 times and the decoction liquid is combined; the decoction time is 30-50 minutes.

[0018] Preferably, in step (3), after collecting the decoction, it is further concentrated and dried.

[0019] Another object of the present invention is to provide a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method, and pharmaceutically acceptable excipients.

[0020] Another object of the present invention is to provide the application of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of a drug for treating or alleviating cerebellar ataxia syndrome.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0022] (1) This invention provides a combination of traditional Chinese medicine formulas for the treatment of cerebellar ataxia syndrome, with the core being tonifying the kidney and replenishing the marrow to benefit the brain, and the auxiliary being strengthening the spleen and eliminating turbidity. The main medicine is highly effective in improving the main symptoms of ataxia such as unsteady walking, balance disorders, and dysarthria. The adjuvant medicines eliminate turbidity and can improve secondary symptoms such as bowel and bladder disorders, sleep disorders, and mental disorders, thereby promoting patient compliance, delaying and stabilizing disease progression, and improving the patient's quality of life.

[0023] (2) The above-mentioned composition provided by the present invention is based on the theory of state-target differentiation and treatment and the dose-effect relationship of traditional Chinese medicine. It uses large doses of prepared and raw Rehmannia glutinosa to tonify the kidneys and replenish marrow as the principal herbs, which not only replenish the functional state of kidney deficiency and marrow depletion, but also specifically restore the clinical target of cerebellar atrophy. Large doses of Cistanche deserticola, Morinda officinalis, Cornus officinalis, and Curculigo orchioides are used as assistant herbs to enhance the kidney-tonifying and marrow-replenishing effects. Dendrobium nobile, Ophiopogon japonicus, and Schisandra chinensis nourish the lungs and kidneys, promoting the mutual generation of metal and water, and strengthening water to control fire; all are assistant herbs. Polygala tenuifolia, Acorus tatarinowii, and Angelica dahurica are added to resolve phlegm, open the orifices, awaken the brain, and restore cerebellar aphasia. Poria cocos, Citrus reticulata, and Amomum villosum strengthen the spleen and aid digestion, while also counteracting the spleen-damaging effects of the nourishing and greasy herbs. The combined use of these herbs is potent and effective, tonifying the kidneys and replenishing marrow, and has a good therapeutic effect on cerebellar ataxia syndrome with kidney deficiency as the main manifestation. Detailed Implementation

[0024] The technical solutions of the present invention will be clearly and completely described below with reference to embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Although representative embodiments of the present invention have been described in detail, those skilled in the art will understand that various modifications and changes can be made to the present invention without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the embodiments, but should be defined by the appended claims and their equivalents.

[0025] Example 1

[0026] A traditional Chinese medicine composition for treating cerebellar ataxia syndrome, comprising: 50 parts raw Rehmannia glutinosa, 50 parts prepared Rehmannia glutinosa, 30 parts Cistanche deserticola, 30 parts Morinda officinalis, 30 parts Cornus officinalis, 15 parts Dendrobium nobile, 10 parts Curculigo orchioides, 10 parts Panax ginseng, 9 parts Ophiopogon japonicus, 10 parts prepared Polygala tenuifolia, 12 parts Acorus tatarinowii, 12 parts Angelica dahurica, 15 parts Poria cocos, 10 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 10 parts Amomum villosum.

[0027] Preparation method:

[0028] (1) Soak raw and processed Rehmannia glutinosa in rice wine for 30 minutes to obtain mixture A.

[0029] (2) Mix the remaining ingredients and add 500ml of purified water to soak for 30 minutes to obtain mixture B.

[0030] (3) After combining mixture A and mixture B, decoct them, collect the decoction, and obtain the Chinese medicine composition.

[0031] In the above preparation method, in step (3), the decoction step involves decocting the mixed raw materials twice and combining the decoctions; wherein, the first decoction is 40 minutes, and the second decoction is 600 ml of water added and decocted for 40 minutes.

[0032] Example 2

[0033] A traditional Chinese medicine composition for treating cerebellar ataxia syndrome, comprising: 20 parts raw Rehmannia glutinosa, 30 parts prepared Rehmannia glutinosa, 15 parts Cistanche deserticola, 15 parts Morinda officinalis, 15 parts Cornus officinalis, 10 parts Dendrobium nobile, 10 parts Curculigo orchioides, 5 parts ginseng, 6 parts Ophiopogon japonicus, 5 parts prepared Polygala tenuifolia, 6 parts Acorus tatarinowii, 6 parts Angelica dahurica, 15 parts Poria cocos, 6 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 5 parts Amomum villosum.

[0034] Preparation method:

[0035] (1) Soak raw and processed Rehmannia glutinosa in rice wine for 10 minutes to obtain mixture A.

[0036] (2) Mix the remaining raw materials and add 500ml of purified water to soak for 10 minutes to obtain mixture B.

[0037] (3) After combining mixture A and mixture B, decoct them, collect the decoction, and obtain the Chinese medicine composition.

[0038] In the above preparation method, in step (3), the decoction step involves decocting the mixed raw materials twice and combining the decoctions; wherein, the first decoction is 30 minutes, and the second decoction is 600 ml of water added and decocted for 30 minutes.

[0039] Example 3

[0040] A traditional Chinese medicine composition for treating cerebellar ataxia syndrome, comprising: 40 parts of raw Rehmannia glutinosa, 100 parts of prepared Rehmannia glutinosa, 25 parts of Cistanche deserticola, 25 parts of Morinda officinalis, 25 parts of Cornus officinalis, 12 parts of Dendrobium nobile, 15 parts of Curculigo orchioides, 8 parts of ginseng, 8 parts of Ophiopogon japonicus, 8 parts of prepared Polygala tenuifolia, 10 parts of Acorus tatarinowii, 10 parts of Angelica dahurica, 25 parts of Poria cocos, 15 parts of Schisandra chinensis, 10 parts of Citrus reticulata peel, and 10 parts of Amomum villosum.

[0041] Preparation method:

[0042] (1) Soak raw and processed Rehmannia glutinosa in rice wine for 50 minutes to obtain mixture A.

[0043] (2) Mix the remaining raw materials and add 800ml of purified water to soak for 40 minutes to obtain mixture B.

[0044] (3) After combining mixture A and mixture B, decoct them, collect the decoction, and obtain the Chinese medicine composition.

[0045] In the above preparation method, in step (3), the decoction step involves decocting the mixed raw materials twice and combining the decoctions; wherein, the first decoction is for 50 minutes, and the second decoction is for 50 minutes with 800 ml of water added.

[0046] The following are some of the formulas screened in the early stages of the experiment.

[0047] Comparative Example 1

[0048] The difference between this comparative example and Example 1 is that the *Curculigo orchioides* is replaced with *Eupatorium fortunei*, as detailed below.

[0049] A traditional Chinese medicine composition, comprising: 50 parts raw Rehmannia glutinosa, 50 parts prepared Rehmannia glutinosa, 30 parts Cistanche deserticola, 30 parts Morinda officinalis, 30 parts Cornus officinalis, 15 parts Dendrobium nobile, 10 parts Epimedium brevicornu, 10 parts Panax ginseng, 9 parts Ophiopogon japonicus, 10 parts prepared Polygala tenuifolia, 12 parts Acorus tatarinowii, 12 parts Angelica dahurica, 15 parts Poria cocos, 10 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 10 parts Amomum villosum.

[0050] Preparation method:

[0051] (1) Soak raw and processed Rehmannia glutinosa in rice wine for 30 minutes to obtain mixture A.

[0052] (2) Mix the remaining ingredients and add 500ml of purified water to soak for 30 minutes to obtain mixture B.

[0053] (3) After combining mixture A and mixture B, decoct them, collect the decoction, and obtain the Chinese medicine composition.

[0054] In the above preparation method, in step (3), the decoction step involves decocting the mixed raw materials twice and combining the decoctions; wherein, the first decoction is 40 minutes, and the second decoction is 600 ml of water added and decocted for 40 minutes.

[0055] Comparative Example 2

[0056] The difference between this comparative example and Example 1 is that the raw material formulation of the composition is different. Details are as follows.

[0057] A traditional Chinese medicine composition, comprising: 50 parts raw Rehmannia glutinosa, 50 parts prepared Rehmannia glutinosa, 30 parts Cistanche deserticola, 30 parts Morinda officinalis, 15 parts Dendrobium nobile, 40 parts Curculigo orchioides, 10 parts ginseng, 9 parts Ophiopogon japonicus, 10 parts prepared Polygala tenuifolia, 12 parts Acorus tatarinowii, 12 parts Angelica dahurica, 15 parts Poria cocos, 10 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 10 parts Amomum villosum.

[0058] Preparation method:

[0059] (1) Soak raw and processed Rehmannia glutinosa in rice wine for 30 minutes to obtain mixture A.

[0060] (2) Mix the remaining ingredients and add 500ml of purified water to soak for 30 minutes to obtain mixture B.

[0061] (3) After combining mixture A and mixture B, decoct them, collect the decoction, and obtain the Chinese medicine composition.

[0062] In the above preparation method, in step (3), the decoction step involves decocting the mixed raw materials twice and combining the decoctions; wherein, the first decoction is 40 minutes, and the second decoction is 600 ml of water added and decocted for 40 minutes.

[0063] Comparative Example 3

[0064] The difference between this comparative example and Example 1 is that the raw material formulation of the composition is different, specifically:

[0065] A traditional Chinese medicine composition, comprising: 50 parts raw Rehmannia glutinosa, 50 parts prepared Rehmannia glutinosa, 30 parts Cistanche deserticola, 30 parts Morinda officinalis, 40 parts Cornus officinalis, 15 parts Dendrobium nobile, 10 parts ginseng, 9 parts Ophiopogon japonicus, 10 parts prepared Polygala tenuifolia, 12 parts Acorus tatarinowii, 12 parts Angelica dahurica, 15 parts Poria cocos, 10 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 10 parts Amomum villosum.

[0066] Preparation method:

[0067] (1) Soak raw and processed Rehmannia glutinosa in rice wine for 30 minutes to obtain mixture A.

[0068] (2) Mix the remaining ingredients and add 500ml of purified water to soak for 30 minutes to obtain mixture B.

[0069] (3) After combining mixture A and mixture B, decoct them, collect the decoction, and obtain the Chinese medicine composition.

[0070] In the above preparation method, in step (3), the decoction step involves decocting the mixed raw materials twice and combining the decoctions; wherein, the first decoction is 40 minutes, and the second decoction is 600 ml of water added and decocted for 40 minutes.

[0071] Comparative Example 4

[0072] The difference from Example 1 is that the cardamom is replaced with white cardamom.

[0073] A traditional Chinese medicine composition, comprising: 50 parts raw Rehmannia glutinosa, 50 parts prepared Rehmannia glutinosa, 30 parts Cistanche deserticola, 30 parts Morinda officinalis, 30 parts Cornus officinalis, 15 parts Dendrobium nobile, 10 parts Curculigo orchioides, 10 parts Panax ginseng, 9 parts Ophiopogon japonicus, 10 parts prepared Polygala tenuifolia, 12 parts Acorus tatarinowii, 12 parts Angelica dahurica, 15 parts Poria cocos, 10 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 10 parts Amomum villosum.

[0074] Preparation method:

[0075] (1) Soak raw and processed Rehmannia glutinosa in rice wine for 30 minutes to obtain mixture A.

[0076] (2) Mix the remaining ingredients and add 500ml of purified water to soak for 30 minutes to obtain mixture B.

[0077] (3) After combining mixture A and mixture B, decoct them, collect the decoction, and obtain the Chinese medicine composition.

[0078] In the above preparation method, in step (3), the decoction step involves decocting the mixed raw materials twice and combining the decoctions; wherein, the first decoction is 40 minutes, and the second decoction is 600 ml of water added and decocted for 40 minutes.

[0079] Experiment 1: Drug Intervention Experiment in an Ataxia Rats

[0080] SPF-grade male SD rats, weighing (220±10)g, were used for 1 week of acclimatization and then divided into 9 groups: normal group, model group, Example 1, 2, 3 groups, and Comparative Example 1, 2, 3, 4 groups, with 8 rats in each group.

[0081] (1) Rotating bar experiment

[0082] The balance and motor coordination of rats were assessed using the Rotamex-5 Rota Rod tester (manufacturer: Columbus Instruments). A 7cm diameter spindle rod was used for the experimental tests. Rats were placed on the rod rotating at 20 rpm for 180 seconds at a time, three times a day, for three days to allow them to acclimatize and remain on the rod.

[0083] Baseline fall latency was established: Baseline performance was then determined using an acceleration mode on days 4 and 7. The acceleration mode involved placing the rat on a rotating bar with an initial rotation speed of 4 rpm and an acceleration of 0.2 rpm, three times a day. The baseline fall latency was calculated as the average of the three longest periods the animal could remain on the bar during the two assessment days.

[0084] Modeling method: On the second day after the baseline latency was measured on day 7, rats other than the normal group were injected intraperitoneally with 3-AP at a dose of 60 mg / kg, while the normal group was injected intraperitoneally with the same volume of physiological saline. The gait of the rats was observed on the second day. The modeled rats exhibited difficulty and clumsiness in movement of the ipsilateral limbs, swaying from side to side, and failing to raise their tails, indicating an inability to coordinate body balance. The model was successfully established.

[0085] Administration method: Three hours after modeling, the traditional Chinese medicine was administered by gavage. The normal group and the model group were given physiological saline by gavage. The traditional Chinese medicine compositions prepared in the corresponding groups were given to the groups of Examples 1, 2, 3 and Comparative Examples 1, 2, 3 and 4 respectively. The dosage was 30g of raw drug / kg, and the gavage was continued for 21 days.

[0086] The fall latency was retested on day 2 and day 21 after the start of administration, with three tests conducted for each test and the average value taken.

[0087] The results of behavioral coordination and fall latency in rats are shown in Table 1 below.

[0088] Table 1

[0089]

[0090] Note: In the same column, compared with the normal group, * P<0.05, ** P<0.01, compared with the model group, & P<0.05, && P<0.01; compared with Example 1 group, # P<0.05, ## P<0.01.

[0091] Experiment 2: Single-arm clinical efficacy trial of the traditional Chinese medicine composition described in this invention.

[0092] 1. Case Information

[0093] 1.1 The cases were 17 patients with cerebellar ataxia syndrome who met the criteria for this study and visited the outpatient clinic of Chief Physician Zhu Wenzong from March 2023 to August 2024.

[0094] 1.2 Diagnostic criteria

[0095] 1.2.1 Western Medicine Diagnostic Criteria

[0096] In modern medicine, cerebellar ataxia syndrome specifically includes the following diseases: hereditary ataxia, multiple system atrophy-cerebellar type, and sporadic adult ataxia.

[0097] Hereditary ataxia (HA): In accordance with the 2024 Chinese Expert Consensus on the Diagnosis and Treatment of Hereditary Ataxia, HA is diagnosed based on molecular genetic testing and family history. The clinical features for auxiliary reference are: (1) chronic onset; (2) progressively worsening symmetrical cerebellar ataxia; (3) relevant neuroimaging, electrophysiological examination, and biochemical indicators; and (4) exclusion of other degenerative diseases involving the cerebellum and brainstem.

[0098] Multiple system atrophy cerebellar type (MSA-C): This study primarily references the "Chinese Expert Consensus on the Diagnostic Criteria for MSA (2022)". The diagnostic criteria classify MSA into four levels: neuropathologically confirmed, clinically confirmed, clinically probable, and probable prodromal MSA. This study included individuals meeting the diagnostic criteria for "clinically confirmed MSA," "clinically probable MSA," and "probable prodromal MSA," with cerebellar ataxia as the initial and / or primary clinical manifestation.

[0099] Sporadic Adult-Onset Ataxia (SAOA): Refer to the diagnostic criteria for SAOA in the 2018 Handbook of Clinical Neurology: (1) progressively worsening symmetrical cerebellar ataxia; (2) adult onset;

[0100] (3) Exclude acute and subacute onset; (4) Complete family history data, excluding familial ataxia history; (5) Exclude evidence of pathogenic gene mutation; (6) Exclude definite acquired etiology; (7) No severe autonomic failure.

[0101] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0102] Referring to "Kidney Essence Deficiency Syndrome" in the "Diagnostic Criteria for Common Syndromes in Traditional Chinese Medicine," and combining the clinical manifestations of cerebellar ataxia syndrome of kidney deficiency and marrow depletion type with the definition of "aphonia and eczema," the following TCM diagnostic criteria for cerebellar ataxia of kidney deficiency and marrow depletion type are comprehensively considered:

[0103] Main symptoms: speech difficulties; unsteady standing; difficulty walking; tremors; fatigue and weakness.

[0104] Secondary symptoms: dizziness; insomnia; forgetfulness; blurred vision; tinnitus, hearing loss; soreness or pain in the lower back and knees; listlessness and taciturnity; cold extremities; weak or constipated bowel movements; frequent urination, nocturia, urinary incontinence; impotence or decreased libido; weak, thready, or weak pulse at the cun position.

[0105] A diagnosis can be made if at least two of the primary symptoms and at least two of the secondary symptoms are present.

[0106] 1.3 Inclusion Criteria

[0107] (1) Meets the diagnostic criteria of Western medicine;

[0108] (2) Meets the diagnostic criteria of Traditional Chinese Medicine;

[0109] (3) Willing to follow the doctor's diagnosis and treatment arrangements, and cooperate with information collection and scale assessment. Regarding concomitant medication: have not previously taken Chinese or Western medicine; or have not taken kidney-tonifying and essence-replenishing Chinese medicine in the two weeks prior to enrollment; or have already taken Western medicine and the efficacy has been stable for at least 30 days, with the Western medicine treatment regimen remaining unchanged or the dosage of Western medicine reduced during the 3-month follow-up treatment.

[0110] 1.4 Exclusion Criteria

[0111] Patients with severe impairment of consciousness, unable to communicate effectively; patients with cerebrovascular disease and leukoencephalopathy; patients with serious primary diseases of the cardiovascular, renal, pulmonary, hepatic, or hematopoietic systems, or patients with mental illness.

[0112] 1.5 Standards for shedding and rejection

[0113] Those who develop serious complications or disease progression during treatment, endangering their lives; those who drop out or are lost to follow-up during observation, including those who are effective in treatment but cannot complete the entire course of treatment, resulting in incomplete clinical data that affects the assessment of efficacy and safety; those who stop taking traditional Chinese medicine on their own, or who take or use other drugs or treatments related to their condition at the same time; those who experience trauma, fractures, or undergo major surgery during treatment, affecting the assessment results; and those who request to withdraw from this clinical study midway.

[0114] 1.6 Ethical Requirements

[0115] This study should strictly follow the Declaration of Helsinki and relevant Chinese regulations on clinical research. Each participant should carefully read and sign the informed consent form.

[0116] 2. Test Plan

[0117] 2.1 Intervention Program

[0118] All patients were treated with the traditional Chinese medicine composition prepared in Example 1, taking one dose daily, consisting of 288g of raw herbs (equivalent to 400ml), divided into two administrations. One course of treatment lasted 90 days, with observation and evaluation conducted before and after the start of each course.

[0119] 2.2 Observation Items

[0120] Scale assessments were conducted before and after treatment, and the scores on each scale were compared before and after treatment. The scale assessments were jointly completed by two neurology graduate students who had received professional scale training. The scales included: the Scale for the Assessment and Rating of Ataxia (SARA), the International Cooperative Ataxia Rating Scale (ICARS), the Activities of Daily Living (ADL) scale, and the Traditional Chinese Medicine syndrome scoring scale.

[0121] 2.3 Safety Evaluation

[0122] Safety evaluations were conducted on patients before and after the experimental intervention. Vital signs and general condition of patients were monitored regularly during follow-up visits. Adverse events that occurred during the experiment were handled and recorded in a timely manner.

[0123] 2.4 Statistical Methods

[0124] Statistical analysis was performed using SPSS 25.0 software. Normally distributed measurement data were expressed as mean ± standard deviation, while non-normally distributed measurement data were expressed as median and interquartile ranges. Paired-samples t-tests were used to compare normally distributed differences, and non-parametric tests were used to compare non-normally distributed differences. A p-value < 0.05 was considered statistically significant.

[0125] 3 Results

[0126] 3.1 The total disorder scores before and after treatment are shown in Table 2.

[0127] Table 2 Comparison of SARA and ICARS scores before and after medication.

[0128]

[0129] As shown in the table above, after 90 days of taking this traditional Chinese medicine composition, the SARA score decreased (p<0.05), indicating a statistically significant difference; the ICARS score also decreased (p<0.05), indicating a statistically significant difference.

[0130] 3.2 The scores of the Activities of Daily Living (ADL) scale before and after treatment are shown in Table 3.

[0131] Table 3 Comparison of ADL scores before and after medication.

[0132]

[0133] As shown in the table above, after 90 days of taking this traditional Chinese medicine composition, the ADL score decreased (p<0.05), indicating a statistically significant difference.

[0134] 3.3 The scores of the TCM syndrome scoring scale before and after treatment are shown in Table 4.

[0135] Table 4 Comparison of scores on the TCM syndrome score scale before and after medication.

[0136]

[0137] As shown in the table above, after 90 days of taking this traditional Chinese medicine composition, the scores on the TCM syndrome score scale decreased (p<0.05), indicating a statistically significant difference.

[0138] 3.4 Adverse Reactions

[0139] Three patients experienced diarrhea during oral administration of this traditional Chinese medicine composition. After adjusting the dosage within the weight range of the traditional Chinese medicine composition, the diarrhea symptoms improved. No other significant adverse reactions were observed, and no patients discontinued the medication due to adverse drug reactions.

[0140] 3.5 Conclusion

[0141] Based on the above results, it can be concluded that the traditional Chinese medicine composition of the present invention can effectively improve the ataxia symptoms of patients with ataxia syndrome, improve their daily living abilities, and improve other related symptoms, thereby enhancing their quality of life. Referring to previous literature data and standards, it can be seen that the traditional Chinese medicine composition has a certain degree of efficacy in delaying or even reversing the progression of the disease.

[0142] Experiment 3: Case Examples

[0143] The patient, a 56-year-old male, is an employee. He presented with unsteady gait and slurred speech for over a year. One year ago, without any obvious cause, he developed unsteady gait, poor balance, and slurred speech. The symptoms gradually worsened, and he sought medical attention at the Second Affiliated Hospital of Wenzhou Medical University, where he was diagnosed with spinocerebellar ataxia type 2 (SCA2). Symptomatic treatment (specific plan unknown) was ineffective, and his symptoms continued to worsen, with abnormal balance, unsteady gait, and limb tremors during movement. He presented to the outpatient clinic in February 2024 with unsteady gait, poor balance, especially noticeable when climbing stairs, a feeling of imbalance while sitting, slurred speech, and a poetic manner of speaking. Sleep was fair, appetite was good, bowel movements were slightly constipated, and urination was normal. Physical examination revealed a wide-gait, positive finger-to-nose test, rapid alternation test (±), difficulty standing with eyes closed (+), inability to complete a straight line, normal muscle strength and tone, and an International Cooperative Ataxia Scale (ICARS) score of 37. The diagnosis was SCA2. The patient's condition was diagnosed as kidney deficiency and marrow depletion according to Traditional Chinese Medicine (TCM). The treatment principle was to tonify the kidneys, replenish essence, and nourish the marrow. The prescription consisted of the herbal composition of this invention: a decoction, one dose taken daily, divided into two warm doses. The patient took the medication for three months, with several follow-up visits during this period. Adjustments were made based on clinical diagnosis within the prescribed dosage range of the herbal composition. At the follow-up visit after three months, the patient's unsteady gait and slurred speech had improved, bowel movements were regular, and the ICARS score was 33. The prescription was continued to consolidate the therapeutic effect.

[0144] The above detailed description is a specific description of one of the feasible embodiments of the present invention. This embodiment is not intended to limit the patent scope of the present invention. All equivalent implementations or modifications that do not depart from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating cerebellar ataxia syndrome, characterized in that, The ingredients, by weight, are: 20-50 parts raw Rehmannia glutinosa, 30-100 parts prepared Rehmannia glutinosa, 15-30 parts Cistanche deserticola, 15-30 parts Morinda officinalis, 15-30 parts Cornus officinalis, 10-15 parts Dendrobium nobile, 10-20 parts Curculigo orchioides, 5-10 parts ginseng, 6-9 parts Ophiopogon japonicus, 5-10 parts Polygala tenuifolia, 6-12 parts Acorus tatarinowii, 6-15 parts Angelica dahurica, 15-30 parts Poria cocos, 6-15 parts Schisandra chinensis, 10-15 parts Citrus reticulata peel, and 5-10 parts Amomum villosum.

2. A traditional Chinese medicine composition for treating cerebellar ataxia syndrome, characterized in that, The ingredients, by weight, are: 20-50 parts raw Rehmannia glutinosa, 30-100 parts prepared Rehmannia glutinosa, 15-30 parts Cistanche deserticola, 15-30 parts Morinda officinalis, 15-30 parts Cornus officinalis, 10-15 parts Dendrobium nobile, 10-20 parts Curculigo orchioides, 5-10 parts ginseng, 6-9 parts Ophiopogon japonicus, 5-10 parts Polygala tenuifolia, 6-12 parts Acorus tatarinowii, 6-15 parts Angelica dahurica, 15-30 parts Poria cocos, 6-15 parts Schisandra chinensis, 10-15 parts Citrus reticulata peel, 5-10 parts Amomum villosum, and 30-100 parts rice wine. The Polygala tenuifolia mentioned is prepared Polygala tenuifolia.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients, by weight, are: 50 parts raw Rehmannia glutinosa, 50 parts prepared Rehmannia glutinosa, 30 parts Cistanche deserticola, 30 parts Morinda officinalis, 30 parts Cornus officinalis, 15 parts Dendrobium nobile, 10 parts Curculigo orchioides, 10 parts ginseng, 9 parts Ophiopogon japonicus, 10 parts prepared Polygala tenuifolia, 12 parts Acorus tatarinowii, 12 parts Angelica dahurica, 15 parts Poria cocos, 10 parts Schisandra chinensis, 10 parts Citrus reticulata peel, and 10 parts Amomum villosum.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The steps include the following: (1) Soak raw and processed Rehmannia glutinosa in a solvent to obtain mixture A; (2) Mix Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium nobile, Curculigo orchioides, Panax ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus tatarinowii, Angelica dahurica, Poria cocos, Schisandra chinensis, Citrus reticulata and Amomum villosum, and soak in water to obtain mixture B; (3) After combining mixture A and mixture B, decoct them and collect the decoction to obtain the final product.

5. The preparation method according to claim 4, characterized in that, The solvent mentioned in step (1) is rice wine, and the soaking time is 10-50 min.

6. The preparation method according to claim 4, characterized in that, The amount of water used in step (2) is 2-8 times the total mass of Cistanche deserticola, Morinda officinalis, Cornus officinalis, Dendrobium nobile, Curculigo orchioides, Panax ginseng, Ophiopogon japonicus, Polygala tenuifolia, Acorus tatarinowii, Angelica dahurica, Poria cocos, Schisandra chinensis, Citrus reticulata and Amomum villosum, and the soaking time is 10-40 min.

7. The preparation method according to claim 4, characterized in that, In step (3), the decoction is performed 1-3 times, and the decoction liquid is combined; the decoction time is 30-50 minutes. And / or, in step (3), after collecting the decoction, it is further concentrated and dried.

8. A pharmaceutical preparation, characterized in that, The traditional Chinese medicine composition is prepared by any one of the traditional Chinese medicine compositions according to claims 1-3 or by any one of the preparation methods according to claims 4-7, and is made with pharmaceutically acceptable excipients.

9. The use of a traditional Chinese medicine composition according to any one of claims 1-3 or a traditional Chinese medicine composition prepared by any one of claims 4-7 in the preparation of a medicament for treating cerebellar ataxia syndrome.

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