Knee Osteoarthritis
Conditions
Keywords
Xinfeng capsule, Knee osteoarthritis, Randomized controlled trials, Double-blind
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.
Interventions
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
DRUGXinfeng 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
Sponsors
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) | up to week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Arthritis pain assessment using the Visual Analog scale (VAS) | baseline,week2,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 |
| 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 |
Countries
China
Outcome results
None listed