Study to evaluate the effect of oral drug levamisol as a supportive therapy to boost the immune system to see its effect in the treatment and prevention of recurrence of warts of the genital region .
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients with genital/venereal warts
- Registration Number
- CTRI/2014/03/004451
- Lead Sponsor
- Dr RML Hospital New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1.Patients with anogenital warts who have not received any topical treatment in last 4 weeks and any systemic therapy in last 12 weeks
2.Patients who are willing to give informed consent
Exclusion Criteria
1.Pregnant females
2.Extensive warts
3.Any topical treatment in last 4 weeks
4.Any systemic therapy in last 12 weeks
5.Giant condyloma acuminate
6.Immunocompromised patients including HIV positivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Rate of the clinical improvement and the immunological parameters mentioned below. <br/ ><br>1 The increase in Th1cytokines (IFN gamma) is likely to be associated with decreased relapse. <br/ ><br>2. Increase in the Th2 cytokines (IL 4 and IL 10) is likely to be associated with delayed therapeutic response and /or relapse. <br/ ><br>3 T reg parameters <br/ ><br>Timepoint: Clinical evaluation at 4 weeks8 weeks12 weeks 24 weeks <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Reduction / prevention of relapseTimepoint: 24 weeks