A study to check safety and effectiveness of â??LeImmune-Tâ?? oil in boosting activity of Natural Killer Cells
- Registration Number
- CTRI/2022/11/047457
- Lead Sponsor
- Phytabolites Neutraceuticals Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
II.Healthy participants having no symptoms of Covid-19
III.Agree to give written consent; for minors, parents/guardians should be ready for participation
IV.Voluntarily participation in the clinical trial
V.Agreeing to follow study procedures
VI.Not participating in any other interventional drug clinical studies before completion of this study
VII.Ready to give medical data for assessments
I.People with symptoms of Covid-19 / RT-PCR positive
II.Allergic to any ingredient of IP i.e. to Tomato or Rice Bran Oil.
III.Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine an increase in the NK Cell Activity in volunteers given a daily dose of 418 microgram/day.Timepoint: 2 Months
- Secondary Outcome Measures
Name Time Method To determine difference in NK cell activity between: <br/ ><br>a) days of consumption <br/ ><br>b) volunteers <br/ ><br>c) Group 1 and 2 <br/ ><br>d) Group 1, 2a and 2b <br/ ><br>e) Group 1 and sub-groups of Group 2 <br/ ><br>f)Sub-groups of Group 1 and sub-groups of Group 2 based on vaccination, prior Covid history etc. <br/ ><br> <br/ ><br>Timepoint: 2 Months