A clinical trial to study in HIV patients the effects of Homoeopathic medicine with the patients who do not require antiretroviral therapy

Not Applicable

Completed

• Conditions: Health Condition 1: null- HIV positive patients who are not on ART and has CD4 count more than or equal to 350 are given homeopathy treatment.Health Condition 2: D848- Other specified immunodeficiencies

• Registration Number: CTRI/2011/12/002228
• Lead Sponsor: Homeopathy India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

Age group-18 to 65 years anf both sexes. 1.HIV sero +ve persons, treat- naive. 2. CD4 more than or equal to 350/cuml 3.VIRAL Load more than 500 copies/cuml 4. Expected life expectancy of more than 12 months.

Exclusion Criteria

HIV sero-negative persons 2. AIDs patients 3. Serious illness4. Viral loadless than 500 copies /cuml5. CD4 less than or equal to 350/cuml6. Patients on ART.7. Clinically suspected tuberculosis (CBC and ESR and X-Ray) who are on or eligible for AKT. 8. Clinically suspected and treated cancer 9. Psoriasis. 10. Lactating and pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Standardization of the new homoeopathy medicine <br/ ><br>2.Safety evaluation. <br/ ><br>3.Efficacy evaluation. <br/ ><br>4.Recording of new symptoms and adverse effects, if any. <br/ ><br>Timepoint: 1.Standardization of the new homoeopathy medicine (It is a procedure, baseline and 6 months) <br/ ><br>2.Safety evaluation( 6 months). <br/ ><br>3.Efficacy evaluation(3 and 6 months). <br/ ><br>4.Recording of new symptoms and adverse effects, if any(3 and 6 months). <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Reduction in HIV viral load compare Baseline <br/ ><br>2.Increase in CD4 count by 20% <br/ ><br>3.Increase in CD8 count form baseline To study change in CD4 percentage <br/ ><br>4.To evaluate the percentage of patients for sustained reduction in viral load. Overall improvement in health (weight, improved appetite, less opportunistic infections) <br/ ><br>Timepoint: Clinical-Every 6weeks. Lab. parameters- three months. ( CD4 and viral Load)