Herbal formulation clinical trial for immune support
Phase 3
Completed
- Registration Number
- CTRI/2020/02/023359
- Lead Sponsor
- Botanic Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Subjects aged 40-70 years of age and of either sex
2. Subjects who were disposed to give consent to the study and willing for follow-
3.Subjects who are willing to sign ICF
Exclusion Criteria
1.Children with genetic disorders, severe or chronic illnesses, congenital diseases, mentally challenged and those on other immunostimulant drugs were excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in TLC from baseline to end of study <br/ ><br>2.Change in AlC from baseline to end f the study <br/ ><br>3.Lymphocyte percentage <br/ ><br>Timepoint: Day 0 Day 28 and Day 56 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Adverse events (AEs), frequency and severity. <br/ ><br>2.Number of subjects who discontinue study due to adverse events <br/ ><br>3.Changes in vital parameters and laboratory investigations. <br/ ><br>Timepoint: Day 0 Day 28 and Day 56