Derris Scandens Benth Extract VS Naproxen in Knee OA

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: naproxen; Drug: Derris scandens Benth extracts

Study type: Interventional

Funder types: Other

Identifiers

NCT00503828

Siriraj CEU 50-001

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

naproxen

Active Comparator group

Description:

Naproxen 500 mg/day for 4 weeks

Treatment:

Drug: naproxen

Derris Scandens Benth

Experimental group

Description:

Derris Scandens Benth

Treatment:

Drug: Derris scandens Benth extracts