Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips.

Study Overview
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Brief Summary
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To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).

Detailed Description
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This trial was a 12 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. Sixty 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 or hip, verified; at least moderate pain during 2 weeks before random assignment to treatment, as identified by the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4. Primary outcome measures were WOMAC at week 12. Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and ESR.

Official Title
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Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: JING CEIH SHERN YUAN EXTRACT PILL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age ≥20 years old 2. Written informed consent obtained 3. Been diagnosed with knee or hip osteoarthritis 4. The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed 5. In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week 6. The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain Exclusion Criteria: 1. Pregnant or breast-feeding women. 2. 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 |
| --- | --- |
| Active Comparator: TCM OA1<br>JING CEIH SHERN YUAN EXTRACT PILL CHUANG SONG ZONG 3 TABLET For 2 Times per day | Drug: JING CEIH SHERN YUAN EXTRACT PILL<br>* Oral use, 3#BID<br>|
| Placebo Comparator: Placebo<br>Placebo 3 TABLET For 2 Times per day | Drug: JING CEIH SHERN YUAN EXTRACT PILL<br>* Oral use, 3#BID<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 12 and week 0 | week 0, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum osteocalcin level | The investigators use serum osteocalcin level to compared the difference between week 12 and week 0 | week 0, week 12 | 
| serum C-terminal telopeptide (CTX) level | The investigators use serum CTX level to compared the difference between week 12 and week 0 | week 0, week 12 | 
| Western Ontario and McMaster Universities (WOMAC) | The investigators use WOMAC to compared the difference between the week 4 and week 0, week 8 and week 0 | week 0, week 4, week 8 | 
| 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, week 12 and week 0 | week 0, week 4, week 8, week 12 | 
| 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, week 12 and week 0 | week 0, week 4, week 8, week 12 | 
| Quality of life by SF-36 | The investigators use SF-36 to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0 | week 0, week 4, week 8, week 12 | 
| High sensitivity C-reactive protein (Hs-CRP) | The investigators use Hs-CRP to compared the difference between the week 12 and week 0 | week 0, week 12 | 
| Erythrocyte sedimentation rate (ESR) | The investigators use ESR to compared the difference between the week 12 and week 0 | week 0, week 12 |