Derris Scandens Benth Extract VS Naproxen in Knee OA
The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 knee-osteoarthritis
Started Jul 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJanuary 13, 2010
June 1, 2009
1.7 years
July 18, 2007
January 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC score
2, 4 weeks
Secondary Outcomes (1)
6-minute walk, Quality of Life, adverse event
2, 4 weeks
Study Arms (2)
naproxen
ACTIVE COMPARATORNaproxen 500 mg/day for 4 weeks
Derris Scandens Benth
EXPERIMENTALDerris Scandens Benth
Interventions
Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks
Eligibility Criteria
You may qualify if:
- Age \>=50 yr
- Known case of primary knee osteoarthritis
- WOMAC pain subscale (item1) \>= 5
- signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mahidol Universitylead
- Ministry of Health, Thailandcollaborator
Study Sites (1)
Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vilai Kuptniratsaikul, Assoc.Prof.
Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 19, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
January 13, 2010
Record last verified: 2009-06