EFFICACY AND SAFETY OF BENJAKUL REMEDY EXTRACT CREAM IN PRIMARY KNEE OSTEOARTHRITIS COMPARING WITH DICLOFENAC GEL (CLINICAL TRIAL PHASE II)

Phase 2

Completed

• Conditions: III of Kellgren & Lawrence criteria.; Diclofenac gel, Osteoarthritis; The patients who were diagnosed as Primary Osteoarthritis of knee with grade I- Benjakul cream&#44

• Registration Number: TCTR20190118003
• Lead Sponsor: Center of Excellence in applied Thai Traddional Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-01-04
• Study Start: 2019-01-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1.Patients aged between 40 †80 years, will be eligible.
2.Get a physical examination and diagnosis of primary osteoarthritis
on every one.
3.Knee pain 3 or more when the evaluation by VAS.
4.No severe symptoms of other diseases.

Exclusion Criteria

1.BMI >32
2.Patients have congenital disease, history of peptic ulcer, diabetes, history of diseases related with cardiac system, liver disease, and kidney disease.
3.Patients have history of allergy to herbs and Diclofenac.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score 14 day Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Pain score 14 day Modified WOMAC score (from Modified Thai WOMAC index)