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

Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02286453

Enrollment

Registered

2014-11-07

Start date

2014-09-30

Completion date

2015-09-30

Last updated

2015-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis of The knee, Benjakul, Alternative Medicine

Brief summary

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)

Interventions

DRUGBenjakul recipe

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

DRUGdiclofenac

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pain score	28 days	Pain score from Visual analog scale

Secondary

Measure	Time frame	Description
Pain score	28 days	Pain score from Modified WOMAC score (from Modified Thai WOMAC index)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026