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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
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 18, 2007
Last Updated
January 11, 2010
Sponsor
Mahidol University
Collaborators
Ministry of Health, Thailand
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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

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Derris Scandens Benth Extract VS Naproxen in Knee OA

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