| CTRI Number |
CTRI/2024/04/065112 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of the cold abdominal pack on stomach activity among healthy individuals. |
|
Scientific Title of Study
|
Immediate effect of cold abdominal pack on electrogastrogram (EGG) among healthy volunteers - A randomized controlled trial |
| 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 Nidhi Pathak |
| Designation |
PG student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy And Yogic sciences |
| Address |
Department of PG studies, Maharishi Aurobindo Subharti College and Hospital of Naturopathy And Yogic sciences, Swami Vivekanand Subharti University
Meerut UTTAR PRADESH 250005 India |
| Phone |
7379778788 |
| Fax |
|
| Email |
nidhipathak2406@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy And Yogic sciences |
| Address |
Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road
Meerut UTTAR PRADESH 250005 India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhay M Shankar Gowda |
| Designation |
Principal |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy And Yogic sciences |
| Address |
Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road
Meerut UTTAR PRADESH 250005 India |
| Phone |
9448300347 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
Source of Monetary or Material Support
Modification(s)
|
|
|
Primary Sponsor
|
| Name |
DR NIDHI PATHAK |
| Address |
Department of PG studies, Maharishi Aurobindo Subharti College and Hospital of Naturopathy And Yogic sciences, Swami Vivekanand Subharti University, Subhartipuram, NH 58, Delhi-Haridwar Bypass Road, meerut, Uttar Pradesh- 250005 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NIDHI PATHAK |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences |
Department of PG Studies, Swami Vivekanand Subharti University, Subhartipuram, Delhi Haridwar Expressway Meerut UTTAR PRADESH |
7379778788
nidhipathak2406@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 |
GASTRIC MOTILITY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COLD ABDOMINAL PACK |
A cold abdominal pack comprising a cotton cloth soaked in water, wrung out, and wrapped around the abdomen from the lower part of the ribs to the groin, will be administered to every patient.
To minimize evaporation, a dry cloth and flannel will be layered over the wet cloth. The temperature for the Cold Abdominal Pack will be 15-16ºC.
All the subjects will receive intervention for 20 minutes.
|
| Comparator Agent |
SHAM TREATMENT |
A dry cotton cloth will be wrapped around the abdomen from the lower part of the ribs to the groin, then again, a dry cloth and flannel will be layered over the dry cloth. The time Duration will be 20 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects who are willing to participate in the study after signing the informed consent form. |
|
| ExclusionCriteria |
| Details |
1 Volunteers with diagnosed medical
conditions.
2 Recent surgeries
3 Cardiovascular co-morbidities
4 Pregnant and lactating women
5 Females undergoing menstruation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ELECTROGASTROGRAM |
PRE AND POST TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF LIFE QUESTIONNAIRE |
PRE AND POST TREATMENT |
|
|
Target Sample Size
|
Total Sample Size="260" Sample Size from India="260"
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)
|
10/04/2024 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Complementary and Alternative Medicine (CAM) use appears to be most common in functional gastrointestinal disorders (FGIDs), a subset of gastrointestinal illnesses. Up to 50% of patients reported using complementary and alternative medicine (CAM), which includes mind-body therapies and biologically active drugs, to alleviate their gastrointestinal problems. Complementary and Alternative Medicine is commonly used in the treatment of digestive illnesses. Hydrotherapy was widely utilized to increase immunity, alleviate pain, encourage flatus or defecation, rehabilitate patients with stomach and gallbladder motor-evacuatory dysfunction, treat peptic ulcers, promote flatus or defecation, and more. One hydrotherapeutic technique used in many naturopathic institutions for a variety of metabolic diseases is the Cold Abdominal Pack which will be used in this research. It is made out of a cotton cloth that has been wrapped around the abdomen after being soaked in cold water and wrung out. To stop evaporation, the wet cloth is additionally covered with a dry cloth and flannel. Enhancing metabolism through thermoregulation is the primary method by which the Cold Abdominal Pack exerts its therapeutic effect. Cold-induced thermogenesis is the fundamental characteristic of endothermic thermoregulation—the capacity to produce heat by speeding up metabolism in reaction to cold. Cold fibers cause transitory afferent discharges when a tiny surface area is exposed to cold, such as during Cold Abdomen Pack application. This results in a drop in skin temperature as well as cold sensation and heat-gain responses. Hypothalamic impulses to constrict peripheral blood arteries are linked to exposure to cold. Consequently, the deeper vascular system experiences compensatory vasodilatation, increasing blood flow to the tissues underneath the site of exposure and raising the metabolic rate to sustain stable deep tissue temperature. For instance, immersion in cold water at 20°C nearly doubles metabolic rate, whereas at 14°C it more than quadruples, according to a prior study. Electrogastrography (EGG) records the myoelectric activity of the stomach that occurs before contractions and uses non-invasive cutaneous electrodes to identify sluggish gastric activity. The slow wave frequency, or the stomach electrical control activity (ECA), determines the periodicity of the sinusoidal impulses that are recorded by the Electrogastrogram (EGG). If the EGG is abnormal, it indicates that the stomach muscles or the nerves that regulate them are most likely the cause of the problem. Scientific data supporting the use of Cold Abdominal Pack for stomach activity is lacking, despite reports of its potential benefits for managing a variety of metabolic conditions. Therefore, the purpose of this study is to determine the impact of a cold abdominal pack on Electrogastrogram among healthy volunteers 30 percent data collection has been done. |