A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Drug: Xinfeng capsule
- Registration Number
- NCT02167516
- Lead Sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
- Participants must meet the American College of Rheumatology (ACR) 1995 revised criteria for KOA.
- Participants must be aged between 40 and 75 years.
- Participants shall not take non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids during the 7 days prior to screening.
- Participants shall not take Chinese medicine for the treatment of KOA during the 7 days prior to screening.
- Joint function in the I-III, X-ray stage in the I-III.
- All participants shall agree to participate in the study and sign an informed consent form.
- Patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity.
- Patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures.
- Persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury .
- Patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases.
- Pregnant women or breastfeeding mothers or individuals with known psychiatric disorders.
- Patients who are hypersensitive to the trial medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xinfeng capsule Xinfeng capsule 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 glucosamine sulfate capsule glucosamine sulfate 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
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster Osteoarthritis Index (WOMAC) up to week 4
- Secondary Outcome Measures
Name Time Method KOA severity using the Lequesne MG score baseline,week2,week4 Bilateral femoral bone mineral density. baseline,week4 Health assessment of the patient refer to the MOS item short from health survey (SF-36) baseline,week4 Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium baseline,week4 Arthritis pain assessment using the Visual Analog scale (VAS) baseline,week2,week4
Trial Locations
- Locations (3)
the First Affiliated Hospital of Anhui University of Chinese Medicine
🇨🇳HeFei, Anhui, China
The Taihe County Hospital of Chinese Medicine
🇨🇳Taihe, Anhui, China
The Tianchang City Hospital of Chinese Medicine
🇨🇳Tianchang, Anhui, China