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

Thammasat University84 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Benjakul recipeDRUG

Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days

diclofenacDRUG

diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Thammasat University (Ruangsit campus)

Khlong Luang, Changwat Pathum Thani, Thailand

Outcomes

Primary Outcomes

Pain score

Pain score from Visual analog scale

Time frame: 28 days

Secondary Outcomes

Pain score

Pain score from Modified WOMAC score (from Modified Thai WOMAC index)

Time frame: 28 days

Data from ClinicalTrials.gov

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