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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

Page last updated: August 23, 2015

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