Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.

Study Overview
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Brief Summary
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Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.

Detailed Description
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This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale. Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4. Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR.

Official Title
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Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis. An Eight-Weeks Double Blind Randomized Placebo-Controlled Clinical Trial.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: TCM OA2
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥20 years old Written informed consent obtained Been diagnosed with knee or hip osteoarthritis The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain Exclusion Criteria: Pregnant or breast-feeding women. Chemotherapy or radiation therapy in cancer patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM OA2<br>TCM OA2 3G BID FOR 8 WEEKS | Drug: TCM OA2<br>* Usage: 3g twice daily<br>* Other names: LIOW WEY DIH HUANG WAN EXTRACT PILL;|
| Placebo Comparator: PLACEBO<br>PLACEBO | Drug: PLACEBO<br>* Usage: 3g twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities (WOMAC) | The investigators use WOMAC to compared the difference between the week 8 and week 0 | week 0, week 4, week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for pain (VAS) | The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0 | week0, week 4 and 8 | 
| Physicians Global Assessment to measure quality of life (PGA) | The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0 | week0, week 4 and week 8 | 
| Quality of life by SF-36 | The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0 | week0, week 2 and week 4 | 
| High sensitivity C-reactive protein (Hs-CRP) | The investigators use Hs-CRP to compared the difference between the week 8 and week 0 | week0, week 8 | 
| Erythrocyte sedimentation rate (ESR) | The investigators use ESR to compared the difference between the week 8 and week 0 | week0, week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese Medicine, Herbs, Liu-wei-die-Huang-Wan