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

August 18, 2015 updated by: Liu Jian, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Efficacy and Safety of Xinfeng Capsule in the Treatment of Knee Osteoarthritis (KOA) :A Randomized, Double-blind, Double-dummy, Multi-center Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • HeFei, Anhui, China, 230031
        • The First Affiliated Hospital of Anhui University of Chinese Medicine
      • Taihe, Anhui, China, 236600
        • The Taihe County Hospital of Chinese Medicine
      • Tianchang, Anhui, China, 239300
        • The Tianchang City Hospital of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: 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
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time Frame: up to week 4
up to week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Arthritis pain assessment using the Visual Analog scale (VAS)
Time Frame: baseline,week2,week4
baseline,week2,week4
KOA severity using the Lequesne MG score
Time Frame: baseline,week2,week4
baseline,week2,week4
Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium
Time Frame: baseline,week4
baseline,week4
Bilateral femoral bone mineral density.
Time Frame: baseline,week4
baseline,week4
Health assessment of the patient refer to the MOS item short from health survey (SF-36)
Time Frame: baseline,week4
baseline,week4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Jian Liu, The First Affiliated Hospital of Anhui University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 15, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1301042211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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