A study to check safety and effectiveness of “LeImmune-T†oil in boosting activity of Natural Killer Cells

Not yet recruiting

• Conditions: Immunogenicity

• Registration Number: CTRI/2022/11/047457
• Lead Sponsor: Phytabolites Neutraceuticals Pvt. Ltd

Brief Summary

Healthy participants having no symptomatic Covid-19agreeing to written consent will be recruited

Oil extract oftomato containing at least 418 microgram beta-carotene per dose(Investigational Product, IP) as provided by Phytabolites Neutraceuticals Pvt.Ltd. shall be administered intimately mixed with their staple cereal based foodequivalent to about half chapatti and consumed with good mastication with thebreakfast every day. Whole bloodsamples will be taken on the day of recruitment (day 0), end of third week (21days), end of one month (30 day), end of two months (60day).

Sample Size calculation

The data shall be a Paired data and shall be analysedby “Analysis of variance’ and has four sets of data for each participant i.e. 0day, 21st day, 31st day and 53rd day. Thus, for statisticalanalysis, total sample size is 50\*4 = 200. Degrees of freedom: Total degrees offreedom: 200-1 = 199, Degrees of freedom for days = 4-1 = 3 and degrees offreedom for Volunteers = 50-1 = 49

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-11-18
• Study Start: 2022-12-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

• 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.	2 Months

Secondary Outcome Measures

Name	Time	Method
To determine difference in NK cell activity between:	a) days of consumption

Trial Locations

Locations (1)

Dr. D. Y. Patil College of Ayurved and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Dr. D. Y. Patil College of Ayurved and Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr Shital Rasane

Principal investigator

9503330831

shital.rasane@dpu.edu.in