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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)  
DR. NIDHI PATHAK 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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