Osteoarthritis
Conditions
Keywords
Traditional Chinese Medicine, Herbs, Liu-wei-die-Huang-Wan
Brief summary
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
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.
Interventions
DRUGTCM OA2
Usage: 3g twice daily
DRUGPLACEBO
Usage: 3g twice daily
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities (WOMAC) | week 0, week 4, week 8 | The investigators use WOMAC to compared the difference between the week 8 and week 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for pain (VAS) | week0, week 4 and 8 | The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0 |
| Physicians Global Assessment to measure quality of life (PGA) | week0, week 4 and week 8 | The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0 |
| Quality of life by SF-36 | week0, week 2 and week 4 | The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0 |
| High sensitivity C-reactive protein (Hs-CRP) | week0, week 8 | The investigators use Hs-CRP to compared the difference between the week 8 and week 0 |
| Erythrocyte sedimentation rate (ESR) | week0, week 8 | The investigators use ESR to compared the difference between the week 8 and week 0 |
Countries
Taiwan
Outcome results
None listed