Effect of Unani Formulation and ibubrofen in the treatment of Osteoarthritis

Phase 2

Recruiting

Conditions: Osteoarthritis

Registration Number: CTRI/2010/091/000585

Lead Sponsor: Central council for research in Unani medicine-CCRUM

Brief Summary: This study is randomised double blinded,single centric to assess the safety & efficacy of Unani formulation in osteoarthritis in India.The primary outcome WOMAC osteoarthritis index, Visual analogue scale (VAS),Active range of motion (AROM).Secondary outcome measuresBiochemical Parameters. These parameters will be done before the treatment and after the completion of the study?Lipidperoxidation 27?Reduced glutathione 28?Superoxide dismutase 29?Catalase 30Radiological parametersX Rays of the affected joints will be taken before and after treatment to compare radiological changes (if any)

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Aged between 40 to 70 yearsEither SexPatients diagnosed according to American College of Rheumatology Criteria for osteoarthritis of different joints will be selected Patients with symptoms consistent with osteoarthritis of the joint involved for at least six months prior to screening.Patients, who will be willing to discontinue all NSAIDs or other analgesic medication taken for any condition, will be included in the test group.Willingness to sign the informed consent, follow the protocol and participate in clinical trial voluntarily.

Exclusion Criteria

Pregnancy and LactationDiabetes mellitusRenal dysfunctionLiver diseases Gastrointestinal diseases(Peptic ulcer disease)Other types of arthritisIHD and hypertensionHistory of surgery of the joint involved Patients who will be unable to read/or understand the WOMAC questionnaire form.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Parameters WOMAC Osteoarthritis Index Visual Analogue Scale (VAS) Active Range Of Motion (AROM)	1

Secondary Outcome Measures

Name	Time	Method
hese Parameters Will Be Done Before The Treatment And After The Completion Of The Study Lipidperoxidation Reduced Glutathione Superoxide Dismutase Catalase Radiological Parameters X Rays Of The Affected Joints Will Be Taken Before And After Treatment To Compare Radiological Changes (If Any)	2

Trial Locations

Locations (1): Majeedia Hospital ,Hamdard University,Hamdard Nagar
🇮🇳
Delhi, DELHI, India
Majeedia Hospital ,Hamdard University,Hamdard Nagar
🇮🇳Delhi, DELHI, India
Mushtaq Ahmad
Principal investigator
9911788213
payermushtaq@gmail.com