Derris Scandens Benth Extract VS Naproxen in Knee OA
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Derris scandens Benth extracts
naproxen
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Derris Scandens Benth extract, Osteoarthritis, WOMAC, 6-minute walk
Eligibility 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
Sites / Locations
- Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
naproxen
Derris Scandens Benth
Arm Description
Naproxen 500 mg/day for 4 weeks
Derris Scandens Benth
Outcomes
Primary Outcome Measures
WOMAC score
Secondary Outcome Measures
6-minute walk, Quality of Life, adverse event
Full Information
NCT ID
NCT00503828
First Posted
July 18, 2007
Last Updated
January 11, 2010
Sponsor
Mahidol University
Collaborators
Ministry of Health, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT00503828
Brief Title
Derris Scandens Benth Extract VS Naproxen in Knee OA
Official Title
The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
Collaborators
Ministry of Health, Thailand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Derris Scandens Benth extract, Osteoarthritis, WOMAC, 6-minute walk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
naproxen
Arm Type
Active Comparator
Arm Description
Naproxen 500 mg/day for 4 weeks
Arm Title
Derris Scandens Benth
Arm Type
Experimental
Arm Description
Derris Scandens Benth
Intervention Type
Drug
Intervention Name(s)
Derris scandens Benth extracts
Intervention Description
Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
naproxen
Intervention Description
Naproxen 500 mg/day for 4 weeks
Primary Outcome Measure Information:
Title
WOMAC score
Time Frame
2, 4 weeks
Secondary Outcome Measure Information:
Title
6-minute walk, Quality of Life, adverse event
Time Frame
2, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilai Kuptniratsaikul, Assoc.Prof.
Organizational Affiliation
Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Derris Scandens Benth Extract VS Naproxen in Knee OA
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