A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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Complementary and alternative medicine has been employed over thousands of years to relieve knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may explored its mechanism. However, presently, there is a lack of large-sample, multicenter, randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA. Therefore, the investigators designed a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of KOA.

Official Title
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Efficacy and Safety of Xinfeng Capsule in the Treatment of Knee Osteoarthritis (KOA) :A Randomized, Double-blind, Double-dummy, Multi-center Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: glucosamine sulfate
* Drug: Xinfeng capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet the American College of Rheumatology (ACR) 1995 revised criteria for KOA. Participants must be aged between 40 and 75 years. Participants shall not take non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids during the 7 days prior to screening. Participants shall not take Chinese medicine for the treatment of KOA during the 7 days prior to screening. Joint function in the I-III, X-ray stage in the I-III. All participants shall agree to participate in the study and sign an informed consent form. Exclusion Criteria: Patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity. Patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures. Persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury . Patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases. Pregnant women or breastfeeding mothers or individuals with known psychiatric disorders. Patients who are hypersensitive to the trial medication.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xinfeng capsule<br>Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks | Drug: Xinfeng capsule<br>* Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks<br>|
| Active Comparator: glucosamine sulfate capsule<br>glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks | Drug: glucosamine sulfate<br>* glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) |  | up to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis pain assessment using the Visual Analog scale (VAS) |  | baseline,week2,week4 | 
| KOA severity using the Lequesne MG score |  | baseline,week2,week4 | 
| Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium |  | baseline,week4 | 
| Bilateral femoral bone mineral density. |  | baseline,week4 | 
| Health assessment of the patient refer to the MOS item short from health survey (SF-36) |  | baseline,week4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xinfeng capsule, Knee osteoarthritis, Randomized controlled trials, Double-blind