Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule in combination,while the other half will receive a Placebo.

Official Title
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Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis:a Randomized, Double-blind, Placebo-controlled Post - Market Clinical Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Treatment of TongBi Capsule
* Drug: Treatment of TongBi placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.45-75 years of age (including 45 years and 75 years old), men and women are not limited. 2. western medicine diagnosis of knee osteoarthritis, clinical classification for primary. 3.The severity of the imaging classification of K-L≤Ⅲ; 4. treatment VAS pain scores than 40mm (select the subjects most obvious limb pain symptoms). 5. informed consent form signed by the patient or legal representative. Exclusion Criteria: within 3 months prior to the trial, the patients were treated within intra-articular treatment. 4 weeks before the treatment, corticosteroids, non steroidal drugs, intra-articular injections or other drugs to improve the condition (such as cartilage protective agents) were used. The screening period has any disease history or evidence: The basic of serious cardiovascular and cerebrovascular diseases; An active, recurrent peptic ulcer or other hemorrhagic disease risk; Sales and other serious diseases of digestive system; An associated with malignant tumors, blood, or other serious diseases or system; Patients who are unable to cooperate or cooperate with other mental disorders. Before the screening, any laboratory test indicators meet the following standards: An admission of liver and kidney function showed that ALT and AST is more than 1.5 times the upper limit of the normal value, Cr is more than 1.2 times the upper limit of normal (Reference Research Center laboratory where the range of normal value); An other clinically significant laboratory abnormalities, and the researchers judged not into the group. Allergic constitution or allergic to TongBi capsul, excipients or similar ingredients; Professional athletes; doubt or indeed history of alcohol and drug abuse; participants who participated in other clinical trials within the first 3 months; the researchers believe that patients should not participate in this clinical trial.

Ages Eligible for Study
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Minimum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment of TongBi Capsule<br> | Drug: Treatment of TongBi Capsule<br>* TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.<br>* Other names: capsule A;|
| Placebo Comparator: Treatment of TongBi Placebo<br> | Drug: Treatment of TongBi placebo<br>* TongBi placebo:0.31g,3times 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 |
| --- | --- | --- |
| The change from Baseline to week 4 in Visual Analog Scale (VAS)score | VAS scores ranges from 0 to 100, with higher scores indicating heavier pain | 0 weeks,2 weeks，4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from Baseline to week 4 in Western Ontarioand McMaster Universities | WOMAC scores ranges from 0 to 96, with higher scores indicating greater disability | 0 weeks,2 weeks and 4 weeks | 
| The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores | SF-36 scores ranges from 0 to 100,it shows the extent of physical function | 0 weeks,4 weeks | 
| The number of adverse events | The number of adverse events related to treatment. | 4 weeks |