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To understand the Adverse Effect profile of a Food and Supplement-Based Detoxification Program in Healthy volunteers

Safety of a Food and Supplement-Based Detoxification Program in Healthy Subjects - CLEAN21

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022146
Enrollment
30
Registered
2019-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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

Sponsors

Organic India
Lead Sponsor
Composite interceptive Med Science Laboratories Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1.To compare the before and after CLEAN, metabolic detoxification score, among volunteers, without serious comorbid illnessTimepoint: Baseline, Visit 2 (Day 1), Visit 3 (Day 8) & Visit 4 (Day 15), Visit 5 (Day 22), and Visit 6 (Day 52)

Secondary

MeasureTime frame
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 Timepoint: 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)

Countries

India

Contacts

Public ContactR C Parasher

Narayana Hrudayalaya

drsigamani@gmail.com91-8071222999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026