Derris Scandens Benth Extract VS Naproxen in Knee OA

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00503828
First received: July 18, 2007
Last updated: January 11, 2010
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Drug: Derris scandens Benth extracts
Drug: naproxen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • WOMAC score [ Time Frame: 2, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6-minute walk, Quality of Life, adverse event [ Time Frame: 2, 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: naproxen
Naproxen 500 mg/day for 4 weeks
Drug: naproxen
Naproxen 500 mg/day for 4 weeks
Experimental: Derris Scandens Benth
Derris Scandens Benth
Drug: Derris scandens Benth extracts
Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503828

Locations
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Ministry of Health, Thailand
Investigators
Principal Investigator: Vilai Kuptniratsaikul, Assoc.Prof. Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
  More Information

No publications provided

Responsible Party: Department of Medical Sciences
ClinicalTrials.gov Identifier: NCT00503828     History of Changes
Other Study ID Numbers: Siriraj CEU 50-001
Study First Received: July 18, 2007
Last Updated: January 11, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Derris Scandens Benth extract
Osteoarthritis
WOMAC
6-minute walk

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014