Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac

Thammasat University

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: diclofenac; Drug: Benjakul recipe

Study type: Interventional

Funder types: Other

Identifiers

NCT02286453

TCTR20140816001 (Registry Identifier)

MTU-EC-ES-6-152/56

Details and patient eligibility

About

Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)

Enrollment: 84 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with primary osteoarthritis of knee with grade I-III of Kellgren & Lawrence criteria
2. Not during breast feeding
3. Not during pregnancy with a good contraception
4. Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
5. Do not abuse drugs
6. Good cooperation

Exclusion criteria

1. BMI > 32
2. History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
3. History of allergy diclofenac or allergy herbal medicine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

1

Experimental group

Description:

Benjakul

Treatment:

Drug: Benjakul recipe

2

Active Comparator group

Description:

diclofenac

Treatment:

Drug: diclofenac