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CTRI Number  CTRI/2025/09/094407 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Case Control Study:Association of Grahani Roga with Psychological Stress 
Scientific Title of Study   A Case Control Study To Establish The Association Between Grahani Roga And Psychological Stress 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrBhagyashri Premraj Wani 
Designation  Post Graduate Student  
Affiliation  APMs Ayurved Mahavidyalaya Sion 
Address  Department of Sanskrit Samhita and Siddhant APMs Sion Ayurved Mahavidyalaya Near Sion railway station Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9607309450  
Fax    
Email  bhagyashri.wani324@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSajay M Satpute  
Designation  Professor  
Affiliation  APMs Ayurved Mahavidyalaya Sion 
Address  Department of Sanskrit Samhita and Siddhant APMs Sion Ayurved Mahavidyalaya Near Sion railway station Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9892982642  
Fax    
Email  Vd.smsatpute@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrSajay M Satpute  
Designation  Professor  
Affiliation  APMs Ayurved Mahavidyalaya Sion 
Address  Department of Sanskrit Samhita and Siddhant APMs Sion Ayurved Mahavidyalaya Near Sion railway station Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9892982642  
Fax    
Email  Vd.smsatpute@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr.Bhagyashri Premraj Wani  
Address  APMs Ayurved Mahavidyalaya Sion Near Sion railway station Mumbai Mumbai  
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 Bhagyashri Premraj Wani   APMs R V Ayurvedic Hospital   OPD No.7 and 10,Ground Floor, Swasthavrutta and Special OPD
Mumbai
MAHARASHTRA 		 9607309450

bhagyashri.wani324@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMs Ayurved Mahavidyalaya Sion IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Case
Age:Patients between 18 and 60 years old
Diagnosis: Clinically diagnosed with Grahani by Ayurvedic texts
With informed consent
Control
Age: Patients between 18 and 60 years old
No history of Grahani or related gastrointestinal disorders

With informed Consent  
 
ExclusionCriteria 
Details  Individuals having severe systemic illness or major surgeries in the recent past
Individuals with history of using drugs such as steroids,NSAIDs, Immunosuppressants
Individuals consuming Alcohol and Tobacco  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe the effect of psychological stress on Grahani   1 day 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the effect of psychological stress on Grahani.
To aware the people about the impact of psychological stress on health.

 		 1 day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   16/09/2025 
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="10"
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   Ayurveda aims at preservation of health and curing of the disease. Ayurveda emphasizes more on the normal condition of Jatharagni (digestive fire)."When the digestive fire (Agni) calms down, the body’s ability to absorb nutrients and
sustain life is lost, leading to death. Conversely, when Agni remains in a state of equilibrium,the body’s functions are optimal.Grahani and Agni are having Adhara-Adheya-Sambandha. Grahani is described as an AgniAdhishthana by most of the acharyas.Grahani is believed to be caused by an imbalance of the doshas (energies) in the body,which can be triggered by stress.Food consumed does not get digested due to distress caused by grief, anger, hunger, etc.For individuals who habitually consume food that is excessively heavy, cold, overly unctuous or in large amounts,channels responsible for transporting bodily fluids (Rasavaha Srotas )become impaired, particularly as a result of persistent and Continuous Chinta.Hence, Stress plays a significant role in the manifestation and exacerbation of Grahani.Psychological stress can disrupt normal digestive functions, leading to various gastrointestinal issues. Addressing psychological stress is therefore an essential component of managing and treating Grahani in Ayurvedic practice.
 
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