Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients. To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.

Detailed Description
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Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis. Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients. To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.

Official Title
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A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Guli capsule
* Drug: Kangguzengsheng capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages between 40 and 70 years, both gender Kellgren and Lawrence grades of I to III; The subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily. Meet the following clinical and radiological criteria for diagnosis: Clinical criteria: most of the time have knee pain nearly a month bone fricative morning stiffness is less than or equal to 30 min age is more than or equal to 38 years bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis. Radiological criteria: most of the time have knee pain nearly a month the X-ray showed osteophyte formation joint fluid examination confirmed with osteoarthritis age is more than or equal to 40 years morning stiffness is less than or equal to 30 min bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6). Exclusion Criteria: Patient with a history of allergy to similar constituents or chemical components of the drug; Patients with limited liver and kidney function; Patients with hematopoietic system disease; Patients with diabetes, Cushing's syndrome and other endocrine disorders; Patients with severe heart and brain disease; Patients with low immunity; Patients directly involved with the staff in the study; Women during pregnancy or lactation; Participating in other clinical studies or Participated in 3 months; The investigators judged who be unfit for the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guli capsule<br>Guli capsule, the tested drug of this study | Drug: Guli capsule<br>* Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day<br>* Other names: GL capsule;|
| Active Comparator: Kangguzengsheng capsule<br>Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study | Drug: Kangguzengsheng capsule<br>* Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day<br>* Other names: KGZS capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale |  | 4 weeks | 
| Number of Participants with Adverse Events as a Measure of Safety |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guli capsule, knee osteoarthritis, Changing of WOMAC and VAS score