| CTRI Number |
CTRI/2025/03/083706 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Colon hydrotherapy on gut flora in overweight and obese patients |
|
Scientific Title of Study
|
Effect of colon hydrotherapy on gut flora among overweight and obese individuals A Randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divisha Tyagi |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami vivekanand Subharti
University Subhartipuram Meerut Uttar Pradesh India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9149338212 |
| Fax |
|
| Email |
divishatyagi1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
Assistant Professor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami vivekanand Subharti
University Subhartipuram Meerut Uttar Pradesh India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami vivekanand Subharti
University Subhartipuram Meerut Uttar Pradesh India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga IPD of Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science of the (CSSH) in Meerut, Uttar Pradesh, India 250005 |
|
|
Primary Sponsor
|
| Name |
Dr. Divisha Tyagi |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road Uttar Pradesh
250005 |
| Type of Sponsor |
Other [Self- Financed] |
|
|
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 Divisha Tyagi |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Maharishi Aurobindo
Subharti College and
Hospital of Naturopathy
and Yogic Sciences
Swami Vivekanand
Subharti University
Subhartipuram NH-58
Delhi-Haridwar Bypass
Road Meerut-250005
Meerut
UTTAR PRADESH |
9149338212
divishatyagi1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) swami vivekanand subharti university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COLON HYDROTHERAPY |
Colon hydrotherapy are
administered to research
participants. Patients must stay in a supine posture for the duration of the
intervention. The colon hydrotherapy, which is given at temperature of 31°C, while the maximum allowable temperature is 39°C. Total duration of the therapy is 45-60 minutes. |
| Comparator Agent |
naturopathy-based eliminative diet chart |
naturopathy-based eliminative diet chart which is given for 3 days continuously
Days Early morning Breakfast Lunch Evening snacks Dinner
Day1 Lemon honey water Fruit juice (mosambi/orange)/
Tender coconut water Boiled Vegetable+
buttermilk+
green salad Fruits, fruit juices(mosambi/orange),
herbal tea/green tea Khichdi/daliya/
boiled vegetable/soup
Day2 Lemon honey water Fruit juice (mosambi/orange) Soup(lauki) Fruit juice (mosambi/orange) Soup
(lauki)
Day3 Lemon honey water Fruit juice
(mosambi/orange) /Tender coconut
water Boiled Vegetable+
buttermilk+
green salad Fruits,
fruit juices
(mosambi/orange)
herbal tea/green tea Khichdi/daliya/
boiled vegetable/soup
Total duration - 3days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI ranging from 25.0 kg/m2 and 39.99 kg/m2
Participants without any previous exposure to Colon hydrotherapy in recent 6 months. |
|
| ExclusionCriteria |
| Details |
Unknown source of hemoptysis [since forced expiration may make
the underlying problem worse].
Pneumothorax
Unstable cardiovascular state, recent myocardial infarction, or
pulmonary embolism, since forceful expiratory maneuvers might
exacerbate angina or alter blood pressure.
Aneurysms in the thorax, abdomen, or brain that run the risk of
rupturing due to elevated thoracic pressure.
Recent surgery of the thorax or abdomen.
Presence of acute disease process that might interfere with the test
performance [e.g. nausea, vomiting]. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Firmicutes/Bacteroidetes ratio. |
at the baseline and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Weight Waist Circumference & Waist Hip
ratio |
At the baseline & post Intervention |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
14/04/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized control trail to find the EFFECT OF COLON HYDRO THERAPY ON GUT FLORA
AMONG OVERWEIGHT AND OBESE INDIVIDUALS on Firmicutes/Bacteroidetes ratio and to test the hypothesis of thecolon hydrotherapy measured by the mean difference in Firmicutes/Bacteroidetes ratio among overweight and obese patients. | Colon hydrotherapy are administered to research participants. Patients must stay in a supine posture for the duration of the intervention. The colon hydrotherapy, which is given at temperature of 31°C, while the maximum allowable temperature is 39°C, after 3 days of naturopathy based eliminative diet. After 45 minutes, the colon hydrotherapy was removed. |
|