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CTRI Number  CTRI/2024/02/063097 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 09/02/2024
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   Gastro Hepatic Pack Treatment for the improvement in Type II Diabetes Mellitus patients. 
Scientific Title of Study   Effect of Gastro Hepatic Pack on Biochemical changes in Type II Diabetes Mellitus patients - A Randomized controlled trail. 
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 M Mownika 
Designation  Post-graduate Scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu. 
Address  184/4, PG Class Room - 1, Department of Naturopathy, Faculty Block (Ground Floor), International Institute of Yoga and Naturopathy Medical Sciences, Kamarajar Nagar, Chengalpattu, Tamil Nadu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  7904068601  
Fax    
Email  mownikamani06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Pandiaraja 
Designation  Head Of Department - Naturopathy (Incharge) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu. 
Address  184/4, PG Class Room - 1, Department of Naturopathy, Faculty Block (Ground Floor), International Institute of Yoga and Naturopathy Medical Sciences, Kamarajar Nagar, Chengalpattu, Tamil Nadu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  9952448729  
Fax    
Email  drpandiarajamuthupandimd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Mownika 
Designation  Post-graduate Scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu. 
Address  184/4, PG Class Room - 1, Department of Naturopathy, Faculty Block (Ground Floor), International Institute of Yoga and Naturopathy Medical Sciences, Kamarajar Nagar, Chengalpattu, Tamil Nadu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  7904068601  
Fax    
Email  mownikamani06@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu.  
 
Primary Sponsor  
Name  Dr M Mownika 
Address  184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (Ground Floor), Department of Naturopathy, Kamarajar Nagar, Chengalpattu, Tamil Nadu. 
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 M Mownika  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu.  184/4, Room No.4, Naturopathic Treatment Room, Department of Naturopathy, Outpatient Block (Ground Floor), International Institute of Yoga and Naturopathy Medical Sciences, Kamarajar Nagar, Chengalpattu, Tamil Nadu.
Kancheepuram
TAMIL NADU 		 7904068601

mownikamani06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Institute of Yoga and Naturopathy Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gastro - Hepatic Pack  Type 2 Diabetes mellitus patients will be given with Gastro - Hepatic Pack for the duration of 4 months (5 days per week). 
Comparator Agent  Yoga and Naturopathic Intervention other than Gastro - Hepatic Pack.  Type 2 Diabetes Mellitus Patients will be given with Yoga and Naturopathic Intervention other than Gastro - Hepatic Pack for the duration of 4 months (5 days per week) 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Type 2 Diabetes mellitus patients with increased HbA1C level. 
 
ExclusionCriteria 
Details  Patients with diabetic systemic complications like diabetic neuropathy, retinopathy & nephropathy. Patients with spinal injury and hernia patients.
Patients who did abdominal and spinal surgery for past year. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Glycated Haemoglobin (HbA1C).  Assessment of Glycated Haemoglobin (HbA1C) will be taken before starting of the study and after completion of the study (4 months). 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of SGOT & SGPT.  Assessment of SGOT & SGPT will be taken before starting of the study and after completion of the study (4 months). 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   29/02/2024 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mownikamani06@gmail.com].

  6. For how long will this data be available start date provided 21-03-2025 and end date provided 20-03-2034?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Due to rising rates of obesity and poor lifestyles, diabetes is becoming a more significant health burden worldwide, particularly in emerging nations like India. In India, over 134 million people were estimated to have diabetes by 2045.Gastro-Hepatic Pack which helps T2DM patient’s blood sugar level. The hot fomentation bag used in the GH pack is placed on the abdomen, which primarily aids in boosting blood flow. This happens because applying heat externally causes the sympathetic nervous system to become less active, which leads to an increase in the volume of hepatic blood. Therefore, a potential mechanism of the GH pack could be a sudden increase in hepatic blood flow that enhances liver function, followed by a reduction in flow that maintains 5–6 times the initial flow and, possibly, the removal of unwanted metabolites from the liver through the processes of phagocytosis. In addition, the vasoconstriction caused by the cold application to the lower back in the GH pack may aid in delivering blood to other bodily parts, such as the liver, where the need for blood supply increases following the application of heat. So, the goal of this study is to assess how GH pack affects individuals with type 2 diabetes mellitus in terms of  HbA1C and SGOT & SGPT. 
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