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CTRI Number  CTRI/2025/04/085428 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of cold and hot abdominal packs on functional dyspepsia: A Three arm randamized controlled trial 
Scientific Title of Study   Impact of Abdominal Pack on Gastric Myoelectrical Activity and Serum Gastrin Level in Functional Dyspepsia: A Three-Arm 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 Yadhushree P V 
Designation  MD Scholar 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India 
Phone  8151985225  
Fax    
Email  yadhushreepv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yadhushree P V 
Designation  MD Scholar 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India 
Phone  8151985225  
Fax    
Email  yadhushreepv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujatha K J 
Designation  Professor and dean 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India 
Phone  9480401646  
Fax    
Email  drsujathadinesh2@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, Shanthivana, Dharmasthala, Belthangadi, Dakshina Kannada, Karnataka, India-574216  
 
Primary Sponsor  
Name  Dr Yadhushree P V 
Address  SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yadhushree P V  Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital, Shanthivana  COE Department of Naturopathy and Therapeutics, Shanthivana, Dharmasthala, Belthangadi- 574216
Dakshina Kannada
KARNATAKA 		 8151985225

yadhushreepv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold Abdominal pack  Cold abdominal pack comprising a cotton cloth 2.5 meters length and 1 meter wide soaked in water, wrung out, and wrapped around the abdomen from the lower part of the ribs to the groin/wetted ice bag made by placing 2000 mL of cubed ice and 300 mL of room-temperature water into the bag application, 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 for 10 days 
Comparator Agent  Dry Abdominal Pack  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. All the subjects will receive control intervention for 20 minutes for 10 days 
Intervention  Hot Abdominal Pack  A hot abdominal pack comprising a Hot Water Bottle/bag placed on the abdomen from the lower part of the ribs to the groin along the abdominal recti muscle borders or on epigastrium, 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 hot abdominal pack will be 50-70 degree celsius. All the subjects will receive intervention for 20 minutes for 10 days. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals who fulfil the functional dyspepsia Rome IV criteria.
2. Subjects who can fast for 8hrs.
3. Subjects who willingly consent to take part in the study procedure and who provide written informed consent authorizing the collection of their personal data.
 
 
ExclusionCriteria 
Details  1. Participants who, within the past year, had an esophagogastroduodenoscopy to confirm a diagnosis of structural gastrointestinal disorder.
2. Participants displaying overt indications of IBS, individuals exhibiting warning signs, such as dysphagia, black or tar stools or weight loss, anatomical abnormalities, paralysis, clotting disorders, leukopenia or seizure disorders.
3. Participants who have undergone gastrointestinal surgery within the last six months.
4. Pregnant or nursing women.
5. Subjects who are intolerant to cold and heat.
6. Subjects with open wound in abdomen and back.
7. Patients who are taking medications that may have an impact on the gastrointestinal tract.
8. Participants with a history of drug or alcohol addiction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Cutaneous Electrogastrography
2. Serum gastrin test
 		 Pre, Post 
 
Secondary Outcome  
Outcome  TimePoints 
EuroQoL 5-dimension (EQ 5D) questionnaire
 		 Pre, Post 
The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)  Pre, post 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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   Phase 2 
Date of First Enrollment (India)   13/05/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   The Rome IV consensus defines functional dyspepsia (FD) as “the presence of symptoms thought to originate in the gastroduodenal region, in the absence of any organic, systemic, or metabolic disease that is likely to explain the symptoms”. The Rome IV criteria define dyspepsia as any combination of four symptoms: early satiety, postprandial fullness, epigastric pain, and epigastric burning that occurs at least three days a week for the past three months, with an onset that occurs at least six months beforehand and is severe enough to interfere with daily activities. Based on this illness’s primary symptoms and potential causes, the Rome IV diagnostic criteria classify FD into epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlapped EPS-PDS subtype. Heartburn, nausea, bloating, and belching are among the other uncomfortable symptoms that many FD patients encounter. Although the exact prevalence of dyspepsia in India is unknown, some research suggests that 7.6-49% of Indians are affected. While there is no correlation between the disease and a higher death rate, the patient’s quality of life is negatively impacted by both physical and psychological discomfort. Psychometric assessments showing feelings of anxiety, depression, and somatization yield higher scores for patients with functional dyspepsia. The hot and cold abdominal pack has been of great assistance in many cases, the results have been so positive and satisfactory that it is nearly unparalleled as a hydriatic procedure in the certainty with which it yields the desired results. This treatment has shown to be particularly effective in both sensory and motor disturbances of the stomach. Ice packs or compresses over the stomach area can enhance the production of hydrochloric acid by the stomach, making it a highly beneficial treatment for hypopepsia. Applying hot fomentations across the stomach for an hour or two after eating can significantly enhance the amount of hydrochloric acid secreted by the peptic glands. In hyperpepsia, the hot douche/pack over the stomach and spine opposite reduces the amount of HCl secreted. In hyperpepsia, the hot douche over the stomach and spine opposite minimizes the amount of HCl secreted. This study intends to evaluate the impact of cold and hot abdominal packs on serum gastrin levels and gastric myoelectrical activity in functional dyspepsia and correlate the hormonal and neural mechanism of dyspepsia before and after the intervention with the dyspepsia symptom score. 
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