Complementary and alternative medicine has been employed over thousands of years to relieve knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may explored its mechanism. However, presently, there is a lack of large-sample, multicenter, randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA. Therefore, the investigators designed a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of KOA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
268
glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks
Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks
the First Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, China
The Taihe County Hospital of Chinese Medicine
Taihe Chengguanzhen, Anhui, China
The Tianchang City Hospital of Chinese Medicine
Tianchang, Anhui, China
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time frame: up to week 4
Arthritis pain assessment using the Visual Analog scale (VAS)
Time frame: baseline,week2,week4
KOA severity using the Lequesne MG score
Time frame: baseline,week2,week4
Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium
Time frame: baseline,week4
Bilateral femoral bone mineral density.
Time frame: baseline,week4
Health assessment of the patient refer to the MOS item short from health survey (SF-36)
Time frame: baseline,week4
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