Traditional Chinese medicine composition for treating hand osteoarthritis

Abstract

The invention discloses a traditional Chinese medicine composition for treating hand osteoarthritis. The traditional Chinese medicine composition comprises the following components in parts by weight: 15-30 parts of astragalus membranaceus, 10-15 parts of ephedra, 15-30 parts of white paeony root stir-fried with bran, 9-15 parts of honey-fried licorice root, 3-5 parts of radix aconiti preparata, 9-15 parts of cassia twig, 10-20 parts of ginger, 15-20 parts of ramulus mori, 12-20 parts of notopterygium root, 10-20 parts of lycopodium clavatum and 15-20 parts of ligusticum wallichii. On the basis of the theory of meridian warming, cold dispelling, muscle resolving and pain relieving of the aconite and cassia twig decoction, astragalus membranaceus is added to tonify qi and strengthen superficies, ramulus mori is added to guide medicine to the upper limbs, lycopodium clavatum is added to relax tendons and activate collaterals, ligusticum wallichii is added to activate blood and promote qi circulation, and the prescription is used for treating the symptoms of morning stiffness, pain, swelling, adverse flexion and extension and the like of hand osteoarthritis with the treatment principles of warming yang and dredging collaterals, tonifying qi and activating blood, dispelling wind and eliminating dampness, and relieving spasm and pain. The composition can be prepared into various dosage forms such as decoction, granules and lotion.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine bone injury and rheumatism rehabilitation technology, and relates to a traditional Chinese medicine composition for treating hand osteoarthritis. Background Technology

[0002] Hand osteoarthritis (HOA) is a common chronic degenerative joint disease, clinically characterized by pain, morning stiffness, swelling, weakness in grasping / pinching, and limited flexion and extension in the proximal / distal interphalangeal joints and the first carpometacarpal joint. Imaging findings may show narrowing of the joint space, osteophyte formation, sclerosis, and / or cystic changes. The disease is chronic and recurrent, with triggering features such as cold, dampness, and overuse. In Traditional Chinese Medicine (TCM), it falls under the categories of "Bi syndrome" and "bone Bi," often caused by wind-cold-dampness obstructing the meridians, combined with qi deficiency and blood stasis, and impaired yang qi circulation, resulting in pain due to lack of nourishment to the tendons and muscles, and stiffness and limited flexion and extension.

[0003] Oral analgesics and anti-inflammatory drugs (NSAIDs / COX-2, acetaminophen, etc.) have a rapid onset of action and can relieve pain in the short term. However, they have limited effectiveness in improving morning stiffness, rigidity, and functional limitations; long-term or elderly patients are prone to adverse gastrointestinal, cardiovascular, and renal reactions; overall, they are difficult to change the course or structural progression of the disease, have a high relapse rate, and affect patient compliance. Topical preparations and physical therapy... The advantages lie in its relatively good safety profile. However, its disadvantages include short duration of pain relief, fluctuating efficacy, and a tendency for recurrence during cold seasons or after heavy lifting; it requires long-term, standardized use and places high demands on patient self-management and compliance. Evidence for injection therapy is inconsistent, and its efficacy is often short-term; injection-related risks exist. Current Western medicines and surgical methods primarily focus on single-target, single-link analgesia, insufficiently addressing core clinical issues such as cold pain triggered by wind, cold, and dampness, morning stiffness, and recurrent pain in multiple joints; furthermore, long-term safety and compliance, as well as sustained improvement in function and quality of life (joint range of motion, grip / pinching strength), remain unsatisfactory. There is an urgent need for a treatment plan that can be managed long-term, individually controlled, and balances pain relief with functional recovery.

[0004] Traditional Chinese medicine (TCM) compound therapy can comprehensively regulate multiple targets and mechanisms, simultaneously achieving multi-dimensional effects such as dispelling wind and cold, warming yang and unblocking collaterals, invigorating qi and promoting blood circulation, and relieving pain. It addresses both the symptomatic aspects of pain and stiffness and the pathogenesis aspects of cold-dampness obstruction and qi deficiency and blood stasis, aligning with the characteristics of hand osteoarthritis as "deficiency in the root and excess in the branch (qi deficiency and yang deficiency, cold-dampness obstruction)." Furthermore, it can be modified according to different syndromes such as predominance of cold-dampness, damp-heat, blood stasis, and liver and kidney deficiency, improving population coverage and individualized application. It is suitable for both acute exacerbations and long-term management during remission and maintenance phases.

[0005] Therefore, developing a traditional Chinese medicine composition that targets HOA, is guided by the principles of TCM syndrome differentiation and treatment, and has a multi-target mechanism of action is of great clinical significance and market potential. Summary of the Invention

[0006] In view of the problems existing in the prior art, the purpose of this application is to provide a traditional Chinese medicine composition for treating osteoarthritis of the hand.

[0007] According to a first aspect of the embodiments of this application, a traditional Chinese medicine composition for hand osteoarthritis is provided, comprising the following traditional Chinese medicine raw materials by weight: 15-30 parts of Astragalus membranaceus, 10-15 parts of Ephedra sinica, 15-30 parts of stir-fried Paeonia lactiflora, 9-15 parts of prepared Glycyrrhiza uralensis, 3-5 parts of prepared Aconitum carmichaelii, 9-15 parts of Cinnamomum cassia, 10-20 parts of Zingiber officinale, 15-20 parts of Morus alba, 12-20 parts of Notopterygium incisum, 10-20 parts of Lycopodium clavatum, and 15-20 parts of Ligusticum chuanxiong.

[0008] Further, by weight, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials: 15-25 parts of Astragalus membranaceus, 10-12 parts of Ephedra sinica, 15-20 parts of stir-fried Paeonia lactiflora, 9-12 parts of prepared Glycyrrhiza uralensis, 3-5 parts of prepared Aconitum carmichaelii, 9-12 parts of Cinnamomum cassia, 10-15 parts of Zingiber officinale, 15-18 parts of Morus alba, 12-15 parts of Notopterygium incisum, 10-15 parts of Lycopodium clavatum, and 15-18 parts of Ligusticum chuanxiong.

[0009] Furthermore, by weight, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials: 15 parts Astragalus membranaceus, 10 parts Ephedra sinica, 15 parts stir-fried Paeonia lactiflora, 9 parts prepared Glycyrrhiza uralensis, 3 parts prepared Aconitum carmichaelii, 9 parts Cinnamomum cassia, 10 parts fresh ginger, 15 parts mulberry twig, 12 parts Notopterygium incisum, 10 parts Lycopodium clavatum, and 15 parts Ligusticum chuanxiong.

[0010] According to a second aspect of the embodiments of this application, the use of the traditional Chinese medicine composition described in any one of the first aspects in the preparation of a medicament for treating osteoarthritis of the hand is provided.

[0011] According to a third aspect of the embodiments of this application, a medicament for treating osteoarthritis of the hand is provided, the medicament being made from the traditional Chinese medicine composition described in the first aspect.

[0012] Furthermore, the medicine is a decoction, granules, or lotion.

[0013] Based on a systematic analysis of the common constitutions and symptoms of patients with hand osteoarthritis, this invention is grounded in the principles of warming the meridians, dispelling cold, relieving muscle tension, and alleviating pain, as exemplified by the formulas of Aconitum carmichaelii Decoction and Cinnamomum cassia, Paeonia lactiflora and Anemarrhena asphodeloides Decoction. Combining this with the clinical characteristics of orthopedics, which emphasizes "simultaneous regulation of tendons and bones, with meridians as the primary focus," it establishes a prescription system that prioritizes "warming yang and unblocking the meridians, supplemented by tonifying qi and activating blood circulation." Prepared Aconitum carmichaelii, Cinnamomum cassia, Zingiber officinale, and Ephedra sinica are used together to warm the meridians, dispel cold, and unblock the meridians to relieve pain. Astragalus membranaceus is added to tonify qi, strengthen the exterior, and expel pathogenic factors, thereby enhancing the effect of expelling pathogenic factors and unblocking the meridians. Fried Paeonia lactiflora with prepared Glycyrrhiza uralensis is used to soothe the liver, relieve spasms, and harmonize the middle jiao. The pain is treated by addressing both internal and external factors. Chuanxiong (Ligusticum striatum) invigorates blood circulation, promotes qi flow, and relieves pain. It is combined with Qianghuo (Notopterygium incisum), Sangzhi (Morus alba twig), and Shenjincao (Lycopodium clavatum) to dispel wind and dampness, guide the medicine to the upper limbs, and relax muscles and tendons. Guizhi (Cinnamomum cassia twig) and Sangzhi (Morus alba twig) work synergistically, enhancing the reach of the medicine to the small joints of the hands and wrists, and together with Shenjincao, improving flexion and extension difficulties. This overall formula creates a synergistic effect of warming the meridians, dispelling cold, and relaxing muscles and tendons. Without significantly increasing the burden on the gastrointestinal tract, cardiovascular system, liver, and kidneys, it shows a more concentrated intervention advantage for HOA syndrome characterized by significant morning stiffness and cold pain. Unlike existing general qi and blood formulas for osteoarthritis, this formula can be used both externally and internally, targeting the upper limb meridians and enhancing safety, highlighting the key point of treating "hand obstruction."

[0014] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Detailed Implementation

[0015] The present invention will be described below through specific embodiments, but the present invention is not limited thereto.

[0016] Unless otherwise specified, the experimental methods used in the following examples are conventional methods; unless otherwise specified, the reagents and materials used in the following examples are commercially available.

[0017] The Astragalus membranaceus, Ephedra sinica, stir-fried Paeonia lactiflora, roasted Glycyrrhiza uralensis, processed Aconitum carmichaelii, Cinnamomum cassia, Zingiber officinale, Morus alba, Notopterygium incisum, Lycopodium clavatum, and Ligusticum chuanxiong used in this invention are all Chinese medicinal materials (dried products), and all comply with the relevant provisions of the various medicinal materials under the main text of Part I of the Chinese Pharmacopoeia (2020 edition). Before being added to the ingredients, each medicinal material was identified, and the actual product matched the name, and the quality met the standards.

[0018] The pathological state of patients with osteoarthritis of the hand is not simple. Most symptoms include morning stiffness, cold pain, difficulty in flexion and extension or worsening with cold, local swelling, pale or dark tongue with thin white or white and greasy coating, and wiry or deep and hesitant pulse.

[0019] Based on this, the present invention provides a traditional Chinese medicine composition for treating osteoarthritis of the hand, comprising the following traditional Chinese medicine raw materials by weight: 15-30 parts of Astragalus membranaceus, 10-15 parts of Ephedra sinica, 15-30 parts of stir-fried Paeonia lactiflora, 9-15 parts of prepared Glycyrrhiza uralensis, 3-5 parts of prepared Aconitum carmichaelii, 9-15 parts of Cinnamomum cassia, 10-20 parts of Zingiber officinale, 15-20 parts of Morus alba, 12-20 parts of Notopterygium incisum, 10-20 parts of Lycopodium clavatum, and 15-20 parts of Ligusticum chuanxiong.

[0020] Preferably, the traditional Chinese medicine composition comprises, by weight, the following raw materials: Astragalus membranaceus 15-25 parts, Ephedra sinica 10-12 parts, stir-fried Paeonia lactiflora 15-20 parts, prepared Glycyrrhiza uralensis 9-12 parts, prepared Aconitum carmichaelii 3-5 parts, Cinnamomum cassia twig 9-12 parts, Zingiber officinale 10-15 parts, Morus alba twig 15-18 parts, Notopterygium incisum 12-15 parts, Lycopodium clavatum 10-15 parts, and Ligusticum chuanxiong 15-18 parts. This allows the prescription to be flexibly adjusted according to the patient's constitution and syndrome differences, while ensuring the balance and safety of its comprehensive effects, including warming yang and dispelling cold, invigorating qi and promoting blood circulation, and relaxing muscles and relieving pain. This also facilitates long-term management and widespread application. More preferably, this traditional Chinese medicine composition, by weight, comprises the following raw materials: Astragalus membranaceus 15 parts, Ephedra sinica 10 parts, stir-fried Paeonia lactiflora 15 parts, prepared Glycyrrhiza uralensis 9 parts, prepared Aconitum carmichaelii 3 parts, Cinnamomum cassia twig 9 parts, Zingiber officinale 10 parts, Morus alba twig 15 parts, Notopterygium incisum 12 parts, Lycopodium clavatum 10 parts, and Ligusticum chuanxiong 15 parts. This composition forms a synergistic axis of warming and invigorating, tonifying Qi, and promoting blood circulation. While ensuring safety, it exhibits rapid onset of action, good tolerability, and more stable preparation and quality control. It can be directly used as a hospital preparation or a standard prescription for industrialization, and its effects on shortening morning stiffness, relieving pain, and improving joint mobility are particularly prominent in patients with osteoarthritis.

[0021] This application also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating osteoarthritis of the hand.

[0022] This application also provides a medicament for treating osteoarthritis of the hand, the medicament being made from the above-mentioned traditional Chinese medicine composition, the medicament being a decoction, granules, or lotion.

[0023] The following is a detailed description with reference to specific embodiments.

[0024] Example 1: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (I) By weight, take 15 parts of Astragalus membranaceus, 10 parts of Ephedra sinica, 15 parts of stir-fried Paeonia lactiflora, 9 parts of roasted Glycyrrhiza uralensis, 3 parts of processed Aconitum carmichaelii, 9 parts of Cinnamomum cassia, 10 parts of fresh ginger, 15 parts of Morus alba, 12 parts of Notopterygium incisum, 10 parts of Lycopodium clavatum, and 15 parts of Ligusticum chuanxiong.

[0025] Example 2: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (II) By weight, take 30 parts of Astragalus membranaceus, 15 parts of Ephedra sinica, 30 parts of stir-fried Paeonia lactiflora, 15 parts of roasted Glycyrrhiza uralensis, 5 parts of processed Aconitum carmichaelii, 15 parts of Cinnamomum cassia, 20 parts of Zingiber officinale, 20 parts of Morus alba, 20 parts of Notopterygium incisum, 20 parts of Lycopodium clavatum, and 20 parts of Ligusticum chuanxiong.

[0026] Example 3: Preparation of the Traditional Chinese Medicine Composition of the Present Invention (Part 3) By weight, take 25 parts of Astragalus membranaceus, 12 parts of Ephedra sinica, 20 parts of stir-fried Paeonia lactiflora, 12 parts of roasted Glycyrrhiza uralensis, 4 parts of processed Aconitum carmichaelii, 12 parts of Cinnamomum cassia, 15 parts of Zingiber officinale, 18 parts of Morus alba, 15 parts of Notopterygium incisum, 15 parts of Lycopodium clavatum, and 18 parts of Ligusticum chuanxiong.

[0027] Example 4: Preparation of the drug of the present invention (I) Weigh each raw material according to the proportions described in Examples 1-3, remove impurities, and slice or crush if necessary. The processed Aconitum carmichaelii used in this product is a qualified processed medicinal slice, and still requires pre-decoction in the preparation process. Place the processed Aconitum carmichaelii separately in a decoction container, add 10 times its weight of water, soak for 30 minutes, then heat to a gentle boil and maintain the pre-decoction for 30-60 minutes. Filter out the pre-decoction. Place the remaining medicinal materials in a decoction container, complete the decoction and filtration according to the prescribed process, add 8-10 times the amount of water (i.e., 8-10 mL of water per 1 g of medicinal material), and soak at room temperature for 30 minutes. Heat to a boil, maintain a gentle boil for 30-40 minutes, filter out the decoction, and combine it with the pre-decoction of processed Aconitum carmichaelii. Add water to the dregs at 6-8 times the total weight of the medicinal materials (i.e., 6-8 mL of water per 1 g of medicinal material), heat again to a boil, maintain a gentle boil for 20-30 minutes, and filter out the decoction. The two decoctions are combined, filtered to remove residue, and prepared into a decoction. Alternatively, it can be concentrated to the desired volume under normal pressure and dispensed into sealed containers. Once prepared, patients can take it directly.

[0028] Example 5: Preparation of the drug of the present invention (II) Weigh the raw materials according to the proportions described in any of Examples 1-3. After removing impurities, pulverize each raw material into coarse powder (passing through a 20-mesh sieve, particle size approximately 850 μm). Soak the prepared Aconitum carmichaelii separately in 10 times its volume of water (10 mL water per 1 g of herb) for 30 min. First decoction: Place the prepared Aconitum carmichaelii in a decoction vessel, add the soaking liquid, and decoct for 60–90 min until gently boiling. Take the coarse powder of the remaining herbs (excluding the prepared Aconitum carmichaelii), add 8 times its volume of water (8 mL water per 1 g of herb), and soak at room temperature for 30 min. Decoct twice: first decoct for 60 min, combine the decoction with the pre-decocted liquid of the prepared Aconitum carmichaelii, then decoct for 40 min. Combine the decoctions and filter out the residue. Concentrate the combined decoction under reduced pressure to a thick paste with a relative density of 1.20–1.25 (60℃); spray dry to obtain a dried extract powder. The obtained extract powder and excipients (dextrin, sucrose powder, honey) are mixed at a mass ratio of extract powder:excipients = 1:1. 60%–70% ethanol is slowly added as a wetting agent at about 15%–20% of the total mass of the soft material to prepare the soft material. The soft material is then granulated using a shaking granulator. The granules are dried with hot air at 60℃, passed through a 16-mesh sieve, and the resulting light brown granules are packaged in composite bags and sealed for storage.

[0029] Example 6: Preparation of the drug of the present invention (Part III) Weigh the raw materials according to the proportions described in any of Examples 1-3. Soak: Except for processed Aconitum carmichaelii, mix the other medicinal materials and add 8-10 times the amount of purified water (8-10 mL of water per 1 g of medicinal material) and soak for 30-45 min; soak processed Aconitum carmichaelii separately in 10 times the amount of water for 30 min. First decoction: Put processed Aconitum carmichaelii into a decoction vessel, add the soaking liquid and decoct for 60-90 min until it boils slightly. Combined decoction—first decoction: Add the remaining medicinal materials and their soaking liquid, combine with the decoction of processed Aconitum carmichaelii, add water to cover the surface of the medicinal materials by 4-5 cm, boil slightly for 60-70 min, filter, and keep the residue. Second decoction: Add 6-8 times the amount of purified water to the residue (6-8 mL of water per 1 g of residue), boil slightly for 40-50 min, and filter. Combine the decoctions from the two decoctions, coarsely filter, and concentrate under reduced pressure below 60℃ to a relative density of 1.05-1.10 (60℃) to obtain the extract for later use. When using, add 3-5 times the volume of water (3-5 mL of water per 1 g of extract) to the above extract to dilute to the required volume, heat to 38-42°C, and wash the affected area externally for 10-20 minutes each time.

[0030] Example 7: Clinical trial of the drug of the present invention for treating osteoarthritis of the hand. 1. Method Forty patients with hand osteoarthritis who met the inclusion and exclusion criteria and were admitted to the outpatient department of Zhejiang Provincial Hospital of Traditional Chinese Medicine between March and July 2025 were prospectively selected using a non-blinded method. They were divided into four groups: a classical prescription group, a mulberry twig group, a *Shenjincao* (a type of herb) group, and a *Tongbi Shujie Fang* (a traditional Chinese medicine composition used in this application) group, with 10 patients in each group. There were no statistically significant differences in age, gender, disease duration, or general characteristics among the patients.

[0031] 2. Diagnostic criteria Western medicine diagnostic criteria: Refer to the 1986 ACR (American College of Rheumatology) diagnostic criteria for hand osteoarthritis. Those meeting the following criteria are eligible: Pain, stiffness, or dysfunction in the joints of the hand (distal interphalangeal joints, proximal interphalangeal joints, or first carpometacarpal joint); Imaging studies suggest joint space narrowing, osteophyte formation, or sclerotic changes; Traditional Chinese Medicine Diagnostic Criteria: According to the "Guidelines for the Diagnosis and Treatment of Bi Syndrome in Traditional Chinese Medicine (2020)", the main symptoms are soreness, cold pain, stiffness or difficulty in flexion and extension of the finger and wrist joints, which may be aggravated by cold. The tongue is pale or dark, the coating is thin white or white and greasy, and the pulse is deep and tight or wiry and hesitant. The syndrome is diagnosed as "wind-cold-dampness bi syndrome".

[0032] 3. Inclusion and Exclusion Criteria Inclusion criteria: (1) Age 40-75 years, gender not limited; (2) Meets the above diagnostic criteria for hand osteoarthritis; (3) Disease duration ≥ 6 months, recent symptoms stable; (4) Signed informed consent form, voluntarily participated in this study and able to cooperate with follow-up; (5) Clinical manifestations mainly of "wind-cold-dampness arthralgia" syndrome. Exclusion criteria: ① Those who do not meet the inclusion criteria; ② Those with other inflammatory joint diseases such as rheumatoid arthritis, gout, and psoriatic arthritis; ③ Those who have used traditional Chinese medicine, Western medicine, or proprietary Chinese medicine that may affect the experimental results within the past 3 months; ④ Those with severe heart, liver, kidney, or hematopoietic system diseases; ⑤ Those who have been treated with glucocorticoids or immunosuppressants within the past month; ⑥ Those who are allergic to drugs such as ephedra, aconite, and cinnamon twig; ⑦ Pregnant or lactating women.

[0033] 4. Treatment Set up the following groups: Classical formula group: Astragalus membranaceus 15g, Ephedra sinica 10g, stir-fried white peony root 15g, prepared licorice root 9g, prepared aconite root 3g, cinnamon twig 9g, fresh ginger 10g, notopterygium incisum 12g, chuanxiong rhizome 15 parts; Mulberry twig group: Astragalus membranaceus 15g, Ephedra sinica 10g, stir-fried white peony root 15g, prepared licorice root 9g, prepared aconite root 3g, cinnamon twig 9g, fresh ginger 10g, notopterygium incisum 12g, chuanxiong rhizome 15g, mulberry twig 15g; The following ingredients were used: Astragalus membranaceus 15g, Ephedra sinica 10g, stir-fried white peony root 15g, prepared licorice root 9g, prepared aconite root 3g, cinnamon twig 9g, fresh ginger 10g, Notopterygium incisum 12g, Ligusticum chuanxiong 15 parts, and Lycopodium clavatum 10g. The formula for relieving pain and relieving joint pain consists of: Astragalus membranaceus 15g, Ephedra sinica 10g, stir-fried white peony root 15g, prepared licorice root 9g, prepared aconite root 3g, cinnamon twig 9g, fresh ginger 10g, Notopterygium incisum 12g, Ligusticum chuanxiong 15g, mulberry twig 15g, and Lycopodium clavatum 10g.

[0034] All four groups received a traditional Chinese medicine wash, applied twice daily, once in the morning and once in the evening. Hands were soaked in the warm wash (40–42℃) for 10–15 minutes, or treated with a wet compress of the same amount of water using soaked gauze for the same duration. Treatment lasted 4 weeks, followed by a 4-week follow-up, using a standardized rehabilitation education program. All four groups also took Celebrex (celecoxib) capsules 200mg orally once daily during the treatment period.

[0035] 5. Observation of therapeutic effects The efficacy assessment time points were set before treatment and 4 weeks after treatment, and the following indicators were observed: Key efficacy endpoints: Visual analog scale (VAS) score for pain; duration of morning stiffness (min); Adverse reaction monitoring: rash, infection, etc.; 6 Statistical Methods Data processing was performed using SPSS 26.0 statistical software. Quantitative data were expressed as mean ± standard deviation (x̄ ± s), and independent samples t-tests were used for comparisons between groups. Categorical data were expressed as frequency and percentage, and chi-square tests were used for comparisons between groups. 2 Tests were performed; rank-sum tests were used for ordinal data. A p-value < 0.05 was considered statistically significant.

[0036] 7 Results There were no statistically significant differences in VAS scores and morning stiffness duration (approximately 30 minutes) among the four groups before treatment (P>0.05). After 4 weeks of treatment, VAS scores and morning stiffness duration in all groups decreased significantly compared to baseline. The improvement was similar in the classical formula group, mulberry twig group, and *Lycopodium clavatum* group, with no statistically significant differences among the groups (P>0.05). In the Tongbi Shujie formula group, VAS decreased by -29.2±7.5 points from baseline, and morning stiffness shortened by -15.7±4.0 minutes, showing a statistically significant difference compared to the classical formula group (P<0.05), and a near-statistical difference compared to the mulberry twig group and *Lycopodium clavatum* group (0.05>P>0.01). No adverse reactions were observed during the follow-up period. It can be seen that, under the overall principles of warming the meridians and promoting circulation, dispelling wind and dampness, and nourishing yin and clearing heat, the introduction of mulberry twigs and *Lycopodium clavatum* shows a synergistic trend that is superior to the simple summation in improving the duration of morning stiffness, cold pain, and difficulty in flexion and extension of the hands, and is especially beneficial to people with upper limb involvement.

[0037] Table 1 Comparison of VAS and duration of morning stiffness before treatment and 4 weeks after treatment (x̄ ± s)

Claims

1. A traditional Chinese medicine composition for treating osteoarthritis of the hand, characterized in that, The ingredients, by weight, include the following Chinese medicinal materials: Astragalus membranaceus 15-30 parts, Ephedra sinica 10-15 parts, stir-fried white peony root 15-30 parts, prepared licorice root 9-15 parts, prepared aconite root 3-5 parts, cinnamon twig 9-15 parts, fresh ginger 10-20 parts, mulberry twig 15-20 parts, Notopterygium incisum 12-20 parts, Lycopodium clavatum 10-20 parts, and Ligusticum chuanxiong 15-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it contains the following Chinese medicinal materials: Astragalus membranaceus 15-25 parts, Ephedra sinica 10-12 parts, stir-fried white peony root 15-20 parts, prepared licorice root 9-12 parts, prepared aconite root 3-5 parts, cinnamon twig 9-12 parts, fresh ginger 10-15 parts, mulberry twig 15-18 parts, Notopterygium incisum 12-15 parts, Lycopodium clavatum 10-15 parts, and Ligusticum chuanxiong 15-18 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it contains the following Chinese medicinal materials: Astragalus membranaceus 15 parts, Ephedra sinica 10 parts, stir-fried white peony root 15 parts, prepared licorice root 9 parts, prepared aconite root 3 parts, cinnamon twig 9 parts, fresh ginger 10 parts, mulberry twig 15 parts, Notopterygium incisum 12 parts, Lycopodium clavatum 10 parts, and Ligusticum chuanxiong 15 parts.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating osteoarthritis of the hand.

5. A medicament for treating osteoarthritis of the hand, characterized in that, The drug is made from the traditional Chinese medicine composition according to any one of claims 1-3.

6. The drug according to claim 5, characterized in that, The medicine is a decoction, granules, or lotion.

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