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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Xinfeng capsule

Intervention Type DRUG

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 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

Group Type ACTIVE_COMPARATOR

glucosamine sulfate

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No