A study to evaluate the efficacy of Ayurvedic medicines Kaisora Guggulu and Madhusnuhi rasayan in the treatment of Gout, a condition associated with painful joints and raised blood levels of uric acid.
Phase 3
- Conditions
- Health Condition 1: null- Patient suffering from joint pain with serum uric acid more than 7mg/dl
- Registration Number
- CTRI/2014/08/004917
- Lead Sponsor
- CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCES JANAKPURI NEWDELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
Inclusion Criteria
FULFILLING THE DIAGNOSTIC CRITERIA AS RECOMMENDED BY THE AMERICAN COLLEGE OF RHEUMATOLOGY (1977)
Exclusion Criteria
PATIENTS WITH TRAUMA, FRACTURE, HEART DISEASE, MALIGNANCY, HYPO-HYPER THYROIDISM, DRUG ABUSERS, PREGNANT, LACTATING WOMEN AND ANY OTHER CONDITION WHICH THE PRINCIPAL INVESTIGATOR THINKS MAY JEOPARDIZE THE STUDY.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MEAN PERCENTAGE DECREASE IN SERUM URIC ACID LEVEL FROM THE BASELINE TO THE END OF THE STUDY.Timepoint: ï??Total Study Period: 24 months <br/ ><br>Pre-trial preparatory period: <br/ ><br>ï?¶Recruitment of staff/Literature survey/ Screening <br/ ><br>of patients/Procurement of medicine etc. : 3 months <br/ ><br>ï?¶Washout Period (if required): 02 weeks <br/ ><br>ï?§Recruitment patients/follow ups/ data recording: 18 months <br/ ><br>ï?§Data analysis/report preparation/ submission: 03 months <br/ ><br>ï?§Treatment Period: 12 weeks <br/ ><br>ï?§Follow-Up Period: 02 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method IMPROVEMENT IN SF-36 HEALTH SURVEY SCORE, PATIENTS GLOBAL ASSESSMENT PAIN VISUAL ANALOGUE SCALE.Timepoint: ï??Total Study Period: 24 months <br/ ><br>Pre-trial preparatory period: <br/ ><br>ï?¶Recruitment of staff/Literature survey/ Screening <br/ ><br>of patients/Procurement of medicine etc. : 3 months <br/ ><br>ï?¶Washout Period (if required): 02 weeks <br/ ><br>ï?§Recruitment patients/follow ups/ data recording: 18 months <br/ ><br>ï?§Data analysis/report preparation/ submission: 03 months <br/ ><br>ï?§Treatment Period: 12 weeks <br/ ><br>ï?§Follow-Up Period: 02 weeks <br/ ><br>