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CTRI Number  CTRI/2025/03/082303 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing and Validating the Agnimandya Concept in Common Childhood Illnesses Versus Healthy Children in the Wardha Area: A Case-Control Study  
Scientific Title of Study   Comparative assessment and validation of the Agnimandya concept in common pediatric ailments versus healthy school going children nearby Wardha  
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Faiz Ahmad Mohammad Firoz Shah 
Designation  PG Scholar 
Affiliation  Datta Megha Institute of Higher Education Research 
Address  Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442107
India 
Phone  8983663313  
Fax    
Email  shahfaiz3513@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Renu Bharat Rathi 
Designation  HOD & Professor 
Affiliation  Datta Meghe Institute of Higher education Research 
Address  Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India 
Phone  9011058302  
Fax    
Email  rbr.226@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Renu Bharat Rathi 
Designation  HOD & Professor 
Affiliation  Datta Megha Institute of Higher Education Research 
Address  Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India 
Phone  9011058302  
Fax    
Email  rbr.226@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda college And Hospital Research center Salod (Hirapur) Wardha 442001 Maharashtra India 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurveda Colleege And Hospital And Research Center Salod Hirapur Wardha 
Address  Department of Kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha 442001 Maharashtra India 
Type of Sponsor  Research institution and hospital 
 
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 
Faiz Ahmad Mohammad Firoz Shah  Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha 442001  Room no 40 Department of Kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA
Wardha
MAHARASHTRA 		 8983663313

shahfaiz3513@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha 442001 Maharashtra India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Unspecified 
Patients  (1) ICD-10 Condition:E639||Nutritional deficiency, unspecified. Ayurveda Condition: KARSHNYAM (KEVALAVATA), (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: VIBANDHA, (3) ICD-10 Condition:J989||Respiratory disorder, unspecified. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Subjects irrespective of sex, religion, socioeconomic status and between the age group of 10-16 years will be taken
Subjects will be assessed with the help of health assessment parameter.
Kasa Subject having classical signs and symptom of Kasa
Karshya Subjects having classical signs and symptoms of Karshya
Vibandha Subjects having classical signs and symptoms of Vibandha
Healthy children with no ongoing health issues
 
 
ExclusionCriteria 
Details  Patients/Participants and patient’s parents who are not willing to participate in this survey.
Other than the three diseases mentioned inclusion criteria
Age below 10 years and more than 16. 
 
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 
The primary outcome of the study would be to compare the levels of Agnimandya (digestive fire) in children with common pediatric ailments versus healthy school-going children. This would involve assessing the digestive health and related symptoms in both groups to validate the concept of Agnimandya in influencing pediatric health  15 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess Agnimandya with the help of questionnaire in context of different disorders & healthy condition with respect to scales for the types of Agni-Samagni, Mandagni, Tikshanagni & vishamagni.  15 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   13/04/2025 
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="0"
Days="15" 
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 - 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 - Data are available indefinitely at (Link to be included shahfaiz3513@gmail.com).

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The study titled "Comparative assessment and validation of the Agnimandya concept in common pediatric ailments versus healthy school-going children nearby Wardha" aims to explore the role of Agnimandya (digestive fire) in children’s health. By comparing children with common pediatric ailments to healthy school-going children, the study seeks to assess how Agnimandya influences digestive health, immunity, and overall well-being. 
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