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Completed

NCT Number: NCT02286453

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

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)

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thammasat University (Ruangsit campus)

Khlong Luang, Changwat Pathum Thani, 10120, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Benjakul recipe

Drug

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

Diclofenac

Drug

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

Primary outcomes

  1. Pain score

    Time frame: 28 days

    Pain score from Visual analog scale

Secondary outcomes

  1. Pain score

    Time frame: 28 days

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

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Collaborators

  • Thai Traditional Medical Knowledge Fund

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2014
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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