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CTRI Number  CTRI/2025/03/082311 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Conceptual and Observational Study to Identify Improper Dietary Factors in Patients with Grahani Roga 
Scientific Title of Study   A CONCEPTUAL AND SURVEY STUDY ON YO HI BHUNKTE VIDHIM TYAKTWA GRAHANI DOSHJAAN GADAAN W.S.R. TO GRAHANI ROGA 
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 Nishi Prabha Singh 
Designation  MD Scholar 
Affiliation  Shri NPA Government Ayurveda College 
Address  Deparment of Samhita Evum Siddhant Shri NPA Government Ayurveda College Raipur (C.G.)
Deparment of Samhita Evum Siddhant Shri NPA Government Ayurveda College Raipur (C.G.)
Raipur
CHHATTISGARH
492001
India 
Phone  8965829842  
Fax    
Email  nishiprabhasingh81@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Singh 
Designation  Lecturer 
Affiliation  Shri NPA Government Ayurveda College 
Address  Deparment of Samhita Evum Siddhant Shri NPA Government Ayurveda College Raipur (C.G.)
Deparment of Samhita Evum Siddhant Shri NPA Government Ayurveda College Raipur (C.G.)
Raipur
CHHATTISGARH
492001
India 
Phone  9575465669  
Fax    
Email  drshewtasingh05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shrikant Naik 
Designation  Lecturer 
Affiliation  Shri NPA Government Ayurveda College Raipur 
Address  Deparment of Samhita Evum Siddhant Shri NPA Government Ayurveda College Raipur (C.G.)
Deparment of Samhita Evum Siddhant Shri NPA Government Ayurveda College Raipur (C.G.)
Raipur
CHHATTISGARH
492001
India 
Phone  8770820337  
Fax    
Email  dr.shrikantnaik@gmail.com  
 
Source of Monetary or Material Support  
Department of samhita evum Shiddhant Shri NPA Government Ayurveda College Raipur (C.G.) 
 
Primary Sponsor  
Name  Deparment of Samhita Evum Siddhant 
Address  Deparment of Samhita Evum Siddhant Shri NPA Government Ayurveda College Raipur (C.G.) 
Type of Sponsor  Government medical college 
 
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 Nishi Prabha Singh  Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh  OPD. No. 2 Kayachikitsha Speciality Clinic 1 and 2 Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
8965829842

nishiprabhasingh81@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Principal Shri NPA Government Ayurveda College Raipur(C.G.)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Who give a consent for study
2. Pre diagnosed patients of Grahani Roga
3. Age between 16 to 60 year
4. Both genders are taken for study
 
 
ExclusionCriteria 
Details  1. Who does not give a consent for study
2. patients have chronic disease
3. Patients of STD, HIV, HbsAg
4. Pregnant and lactating Women
5. less the age of 16 year and above 60 year are excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Grahani Roga happens due to improper dietary factors  6 month to 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Grahani Roga does not happens due to improper dietary factors  6 month to 1 year 
This study will help to understanding Aahar vidhi (dietary methods) described in the scriptures from contemporary perspective.  6 month to 1 year 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   31/03/2025 
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="1"
Months="0"
Days="0" 
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 - NO
Brief Summary  

INTRODUCTION

Adequate nutrition is necessary for a healthy life, but consuming food without knowing the method of diet cannot provide good health benefits. The method of diet plays an important role in both the origin and treatment of diseases. Food is the life of living beings. Descriptions of many types of instructions related to the method of diet are available here and there, but the Ashta Ahara Vidhi Visheshayatana (eight dynamics must be measured before taking food) described in Ayurveda Shastra, visheshayatan, diet method (vidhan) have their own special importance. Acharya Charak has described the importance of diet method that, by consuming food in a proper manner, after proper digestion by the gastric fire, the Rasaadi dhatu are strengthened and the body remains full of age and strength. If a person consumes food without following the rules of diet due to greed or the restlessness of the tongue, then his digestive fire gets distorted and distorts the Grahani and Grahani dependent disorders arise. There is a support-dependent relationship between Grahani and fire. Therefore, when the Grahani is contaminated, the fire gets distorted. Contaminated fire cannot digest even small food.  That unripe food/ama on receiving the suktatva produces aama toxin which shows harmful effects like poison in the body.

Charak has considered Aam Toxin to be an independent origin due to the slowing down of the digestive fire. This common toxin contaminates the doshas, dhatu and malas again and gives rise to various types of disease groups in the entire body. Grahani is not a single disease but a group of disorders.


NEED OF STUDY
Nowadays, Grahani Roga (duodenal disease) are occurring in abundance, the main reason for which is improper dietary habits.
In modern times, due to busy and competitive lifestyle, dietary habits have changed a lot. Society is giving the least importance to diet and diet method. At present, various types of metabolic non-communicable diseases are arising prematurely in every age group, especially children and youth, in which obesity, high blood pressure, heart disease, cancer, mental stress and depression are the major ones. In Ayurveda, the root cause of Grahani Roga (duodenal disease) is the disorder of Agni and improper food intake. Such diseases can be avoided by making positive changes in wrong habits related to the method of eating. Diet method is a very important link between the consumption of nutritious food and health benefits.
The basic treatment principle of duodenal disease is to bring the jatharagni (gastric fire}, dhatvagni and bhutagni to a balanced state. For this, along with medical treatment, it is very important to follow the diet prescribed in scriptures for a long time. Therefore, it is necessary to study the diet in the current perspective while making the general public aware of both the prevention and treatment of duodenal disease.
 
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