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NCT Number: NCT02167516

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

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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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucosamine Sulfate

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

Xinfeng capsule

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

Primary outcomes

  1. Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    Time frame: up to week 4

Secondary outcomes

  1. Arthritis pain assessment using the Visual Analog scale (VAS)

    Time frame: baseline,week2,week4

  2. KOA severity using the Lequesne MG score

    Time frame: baseline,week2,week4

  3. Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium

    Time frame: baseline,week4

  4. Bilateral femoral bone mineral density.

    Time frame: baseline,week4

  5. Health assessment of the patient refer to the MOS item short from health survey (SF-36)

    Time frame: baseline,week4

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Jun 19, 2014
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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