Derris Scandens Benth Extract VS Naproxen in Knee OA
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Knee Osteoarthritis
Intervention: Derris scandens Benth extracts (Drug); naproxen (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Vilai Kuptniratsaikul, Assoc.Prof., Principal Investigator, Affiliation: Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
Summary
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.
Clinical Details
Official title: The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: WOMAC score
Secondary outcome: 6-minute walk, Quality of Life, adverse event
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Siriraj Hospital, Bangkoknoi, Bangkok 10700, Thailand
Additional Information
Starting date: July 2007
Last updated: January 11, 2010
|