Derris Scandens Benth Extract VS Naproxen in Knee OA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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naproxen

Naproxen 500 mg/day for 4 weeks

Group Type ACTIVE_COMPARATOR

naproxen

Intervention Type DRUG

Naproxen 500 mg/day for 4 weeks

Derris Scandens Benth

Group Type EXPERIMENTAL

Derris scandens Benth extracts

Intervention Type DRUG

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

Interventions

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Derris scandens Benth extracts

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

Intervention Type DRUG

naproxen

Naproxen 500 mg/day for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes