| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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 STUDYNowadays, 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. |