Osteoarthritis
Conditions
Brief summary
To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).
Detailed description
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.
Interventions
DRUGJING CEIH SHERN YUAN EXTRACT PILL
Oral use, 3#BID
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities (WOMAC) | week 0, week 12 | The investigators use WOMAC to compared the difference between the week 12 and week 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum C-terminal telopeptide (CTX) level | week 0, week 12 | The investigators use serum CTX level to compared the difference between week 12 and week 0 |
| Western Ontario and McMaster Universities (WOMAC) | week 0, week 4, week 8 | The investigators use WOMAC to compared the difference between the week 4 and week 0, week 8 and week 0 |
| Visual Analog Scale for pain (VAS) | week 0, week 4, week 8, week 12 | 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 |
| serum osteocalcin level | week 0, week 12 | The investigators use serum osteocalcin level to compared the difference between week 12 and week 0 |
| Quality of life by SF-36 | week 0, week 4, week 8, week 12 | 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 |
| High sensitivity C-reactive protein (Hs-CRP) | week 0, week 12 | The investigators use Hs-CRP to compared the difference between the week 12 and week 0 |
| Erythrocyte sedimentation rate (ESR) | week 0, week 12 | The investigators use ESR to compared the difference between the week 12 and week 0 |
| Physicians Global Assessment to measure quality of life (PGA) | week 0, week 4, week 8, week 12 | 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 |
Outcome results
None listed