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Derris Scandens Benth Extract VS Naproxen in Knee OA

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00503828
Enrollment
120
Registered
2007-07-19
Start date
2007-07-31
Completion date
2009-03-31
Last updated
2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Derris Scandens Benth extract, Osteoarthritis, WOMAC, 6-minute walk

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.

Interventions

DRUGDerris scandens Benth extracts

Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks

DRUGnaproxen

Naproxen 500 mg/day for 4 weeks

Sponsors

Ministry of Health, Thailand
CollaboratorOTHER_GOV
Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
WOMAC score2, 4 weeks

Secondary

MeasureTime frame
6-minute walk, Quality of Life, adverse event2, 4 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026