| CTRI Number |
CTRI/2019/11/022146 [Registered on: 26/11/2019] Trial Registered Prospectively |
| Last Modified On: |
17/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To understand the Adverse Effect profile of a Food and Supplement-Based Detoxification Program in Healthy volunteers |
|
Scientific Title of Study
|
Safety of a Food and Supplement-Based Detoxification Program in Healthy Subjects |
| Trial Acronym |
CLEAN21 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DCOI/CLEAN21-19/001;Version 1.0, Dated 02 October 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paul Salins |
| Designation |
Chairman |
| Affiliation |
CIMED |
| Address |
Room no 3, Second Floor, Plot No.2702, Pragati Plaza, Hebbagodi, Hosur Road
Bangalore
KARNATAKA
560099
India |
| Phone |
8071222999 |
| Fax |
|
| Email |
oncologyresearchnh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alben Sigamani |
| Designation |
Consultant, Head Clinical Research |
| Affiliation |
Narayana Hrudayalaya |
| Address |
258/A, Bommasandra Industrial Area Anekal Taluk, Hosur Rd, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
91-8071222999 |
| Fax |
|
| Email |
drsigamani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R C Parasher |
| Designation |
Sr. General Manager-Quality & NPD |
| Affiliation |
Organic India Pvt Ltd |
| Address |
Plot 266, Kamta,Near Crystal View Apartments Faizabad Road Kamata, Chinhat,
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
|
| Fax |
|
| Email |
parasher@organicindia.com |
|
|
Source of Monetary or Material Support
|
| Composite Interceptive Med Science Laboratories Pvt. Ltd
Plot No.2702, Room no 3, Second Floor, Pragati Plaza, Hebbagodi, Hosur Road |
|
|
Primary Sponsor
|
| Name |
Organic India |
| Address |
Plot 266, Kamta, Near Crystal View Apartments,
Faizabad Road, Chinhat,
Lucknow-226028, Uttar Pradesh Karnataka
|
| Type of Sponsor |
Other [Nutraceutical Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Composite interceptive Med Science Laboratories Pvt Ltd |
2nd Floor Pragati Plaza, Hebbagodi, Hosur Road,
Bangalore - 560099, Karnataka
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr L Sucharitha |
Shettys Hospital |
Room No. 1, First Floor, Dept. of Ayurveda, Plot No.11 &12, 12th F main, Kaveri Nagar, Bommanahalli
Bangalore
KARNATAKA |
08040416789
sucharitha.pandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shettys Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLEAN 21 Kit |
This is a 21-day treatment program with kits that includes Smoothie packets (to be taken twice daily), wellness infusions (to be taken thrice after every major meal), and 5 types of supplements consisting of triphala, bowelcare, Neem, Turmeric, Liver and Kidney care capsules (to be taken thrice in a day, after each major meal), and Tulsi-lax to be taken only if the whole day goes by without bowel movement, either before bed or in the early morning |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age above 21 years and below 65 years
2.Either gender
3.Literate Subjects (with English speaking skills) who are willing to consent for 21day program under supervision (telephonic and Social Network), self-motivated to complete the program
|
|
| ExclusionCriteria |
| Details |
1.Know history of food allergies or positive for IgG for 22 known food allergens.
2.Women in child bearing age, married or potential to be pregnant, refusing to perform a pregnancy confirmation test to rule out pregnancy.
3.Women breast feeding or within 6 months post-partum.
4.Use of prescription and non-prescription medication and/or nutritional supplements/medical foods for the support of detoxification in the past 3 months or taking regular medication for diabetes, hypertension or dyslipidaemia and not showing adequate control as per standard guidelines or likely to have changes in their prescription during the 21 day program.
5.Anyone to have changed their physical activity significantly 2 weeks before the study and throughout the duration of the study.
6.Active disease undergoing intensive or continuation therapy for any illness.
7.Unlikely to be able to stay compliant to the program for reasons discussed with the clinician
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the before and after CLEAN, metabolic detoxification score, among volunteers, without serious comorbid illness |
Baseline, Visit 2 (Day 1), Visit 3 (Day 8) & Visit 4 (Day 15), Visit 5 (Day 22), and Visit 6 (Day 52) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the changes in baseline inflammatory screening panel, before and after CLEAN
2.To record incidence of any side effects to the CLEAN program
|
1.Baseline Visit & Visit 5 (22nd Day)
2. Baseline, Visit 2 (Day 1), Visit 3 (Day 8) & Visit 4 (Day 15), Visit 5 (Day 22), and Visit 6 (Day 52)
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The Study outcome will be published by the sponsor after the completion of study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This proposed study is a prospective, cohort, non-randomized single arm, pre- and post intervention study in healthy volunteers aged 21 to 65 Years. The primary endpoint is to establish the safety of a food and supplement based detoxification program among healthy subjects using the Metabolic Detoxification Questionnaire (MDQ). The total number of visits include 21 days of detoxification and four weeks of washout. |