A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Drug: glucosamine sulfate; Drug: Xinfeng capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02167516

1301042211

Details and patient eligibility

About

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.

Enrollment: 268 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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268 participants in 2 patient groups

Xinfeng capsule

Experimental group

Description:

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

Treatment:

Drug: Xinfeng capsule

glucosamine sulfate capsule

Active Comparator group

Description:

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

Treatment:

Drug: glucosamine sulfate