| CTRI Number |
CTRI/2024/05/066937 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Cold and neutral enema on HRV, blood pressure and pulse rate |
|
Scientific Title of Study
|
The Effect of Cold and Neutral Water Enema on Autonomic Variables among Healthy Volunteers- A Comparative Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhiraj Gautam |
| Designation |
Post Graduate Scholar |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences |
| Address |
PG scholar Room, Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
955487424 |
| Fax |
|
| Email |
Dhirajgautam07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences |
| Address |
Department of PG Studies, Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, 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 |
| Affiliation |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences |
| Address |
Principal Office, Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9448300347 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Dr. Dhiraj Self-Financed, Swami Vivekanand Subharti University & Chhatrapati Shivaji Subharti Hospital,Meerut ,India,pin 250005 |
|
|
Primary Sponsor
|
| Name |
Dr Dhiraj Gautam |
| Address |
Swami Vivekanand Subharti University Subhartipuram,NH-58,Delhi-Haridwar Bypass Road, Meerut,india,250005 |
| Type of Sponsor |
Other [Self] |
|
|
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 Dhiraj Gautam |
Maharishi aurobindo subharti college & hospital of naturopathy & yogic sciences ,IPD |
Swami vivekanand subharti university,subhartipuram, NH-58 delhi- haridwar highway, meerut
Meerut
UTTAR PRADESH |
9554874024
dhirajgautam07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Un specific |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold Enema |
cold enema are administered to research participants.Using Cold water with temperature 70-80°F and the amount of water is 900ml. Put enema cathetor in Anus region to fill with water in rectum and colon .
|
| Comparator Agent |
Neutral Enema |
Using neutral water with temperature 98°F and the amount of water is 900ml. Put enema cathetor in Anus region to fill water in rectum and colon
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers with no existing medical conditions.
Subjects who are ready to participate in the study after signing the informed consent form. |
|
| ExclusionCriteria |
| Details |
Secondary hypertension.
Pregnancy and menstrual period.
Subjects under the influence of any psychoactive substance.
Arteriovenous fistula site of infection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability (HRV) |
Before and after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood pressure
Pulse Rate |
Before and after |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/05/2024 |
| Date of Study Completion (India) |
28/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to conduct a comparative study on Cold and Neutral Enema to diagnosed the Heart rate variability ,Blood pressure and Pulse rate. The objective is to assess the impact of Cold and neutral Enema on heart rate variability, blood pressure and pulse rate. These enema therapy have been recognised as effective in heart rate variability; however no comparative study has been conducted among the Indian population to date, specifically heart rate variability,as well as systolic and diastolic blood pressure and pulse rate as secondary outcomes of the study. |