Derris Scandens Benth Extract VS Naproxen in Knee OA

Knee Osteoarthritis Clinical Trial

Official title:

The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503828
• Other study ID #: Siriraj CEU 50-001
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2007
• Last updated: January 11, 2010
• Start date: July 2007
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Derris scandens Benth extracts
Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks
• naproxen
Naproxen 500 mg/day for 4 weeks

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC score		2, 4 weeks	No
Secondary	6-minute walk, Quality of Life, adverse event		2, 4 weeks	Yes