| CTRI Number |
CTRI/2022/11/047457 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to check safety and effectiveness of “LeImmune-T†oil in boosting activity of Natural Killer Cells |
|
Scientific Title of Study
|
A prospective interventional study to determine safety and efficacy of “LeImmune-T†oil in improving/restoring activity of Natural Killer Cells |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shital Rasane |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Associate Professor, Room 17A,Dept. of Ayurved Samhita Siddhant, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri-Chinchwad, Maharashtra 411018
Associate Professor, Room 17A,Dept. of Ayurved Samhita Siddhant, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9503330831 |
| Fax |
|
| Email |
shital.rasane@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hrishikesh Rangnekar |
| Designation |
Director |
| Affiliation |
Quest Clinical Services |
| Address |
Room D204, Sun Planet, Sun city area, Sinhagad Road, Pune 411051
Room D204, Sun Planet, Sun city area, Sinhagad Road, Pune 411051
Pune
MAHARASHTRA
411051
India |
| Phone |
9890901109 |
| Fax |
|
| Email |
dr.rangnekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hrishikesh Rangnekar |
| Designation |
Director |
| Affiliation |
Quest Clinical Services |
| Address |
Room D204, Sun Planet, Sun city area, Sinhagad Road, Pune 411051
Room D204, Sun Planet, Sun city area, Sinhagad Road, Pune 411051
Pune
MAHARASHTRA
411051
India |
| Phone |
9890901109 |
| Fax |
|
| Email |
dr.rangnekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Phytabolites Neutraceuticals Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
Phytabolites Neutraceuticals Pvt. Ltd |
| Address |
Rameshwar Apartment, Near Mahila Bank,Indira Nagar,, Nashik, Maharashtra 422009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shital Rasane |
Dr. D. Y. Patil College of Ayurved and Research Centre |
Dept of Ayurved Samhita Siddhant of DYP College, Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
9503330831
shital.rasane@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D. Y. Patil College of Ayurved and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunogenicity |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: LeImmune-T, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 418(NA), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 53 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine an increase in the NK Cell Activity in volunteers given a daily dose of 418 microgram/day. |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine difference in NK cell activity between:
a) days of consumption
b) volunteers
c) Group 1 and 2
d) Group 1, 2a and 2b
e) Group 1 and sub-groups of Group 2
f) Sub-groups of Group 1 and sub-groups of Group 2 based on vaccination, prior Covid history etc.
|
2 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Healthy participants having no symptomatic Covid-19
agreeing to written consent will be recruited
Oil extract of
tomato 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 food
equivalent to about half chapatti and consumed with good mastication with the
breakfast every day. Whole blood
samples will be taken on the day of recruitment (day 0), end of third week (21
days), end of one month (30 day), end of two months (60 day). Sample Size calculation
The data shall be a Paired data and shall be analysed
by “Analysis of variance’ and has four sets of data for each participant i.e. 0
day, 21st day, 31st day and 53rd day. Thus, for statistical
analysis, total sample size is 50*4 = 200. Degrees of freedom: Total degrees of
freedom: 200-1 = 199, Degrees of freedom for days = 4-1 = 3 and degrees of
freedom for Volunteers = 50-1 = 49 |