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Completed

NCT Number: NCT00503828

Derris Scandens Benth Extract VS Naproxen in Knee OA

Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age >=50 yr
  • Known case of primary knee osteoarthritis
  • WOMAC pain subscale (item1) >= 5
  • signed informed consent

Exclusion criteria

  • hypersensitive to NSAIDs
  • history of peptic ulcer or melena
  • unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction
  • history of intra-articular injection of knee within 3 months
  • status post knee replacement

Treatment and study plan

Derris scandens Benth extracts

Drug

Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks

Naproxen

Drug

Naproxen 500 mg/day for 4 weeks

Primary outcomes

  1. WOMAC score

    Time frame: 2, 4 weeks

Secondary outcomes

  1. 6-minute walk, Quality of Life, adverse event

    Time frame: 2, 4 weeks

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Ministry of Health, Thailand

Registry information

Official study title

The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 19, 2007
Registry last updated
Jan 13, 2010

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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