Osteoarthritis Clinical Trial
Official title:
Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.
To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).
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.
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