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 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 KOA severity using the Lequesne MG score baseline,week2,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
the First Affiliated Hospital of Anhui University of Chinese Medicine🇨🇳HeFei, Anhui, China