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CTRI Number  CTRI/2025/12/099132 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 14/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   It is a study to see how much effective is Ayurvedic medicine Mustakadi Churna in the treatment of Grahani 
Scientific Title of Study   Single arm clinical study to evaluate efficacy of Mustakadi Churna in the management of Grahani with special reference to Irritable Bowel Syndrome in the children of Age 8to 16 Yrs  
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 swapnil devkate  
Designation  Pg Scholar 
Affiliation  LRP Ayurvedic Medical College and Hospital 
Address  LRP Aurvedic medical college and hospital, PG Institute and Research center, Urun Islampur, Sangli, Department of kaumarbhritya, OPD 2 Sangli Maharashtra
LRP Aurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Department of kaumarbhritya OPD 2 Sangli Maharashtra
Sangli
MAHARASHTRA
415409
India 
Phone  9970231197  
Fax    
Email  swapnildevkate07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Masaudaalam Mujawar 
Designation  Professor  
Affiliation  LRP Ayurvedic medical college and hospital, PG Institute and Research institute  
Address  LRP Ayurvedic medical college and hospital, PG Institute and Research center Urun Islampur kaumarbhritya department OPD 2 Sangli Maharashtra 415409
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur, kaumarbhritya department, OPD 2 Sangli Maharashtra 415409
Sangli
MAHARASHTRA
415409
India 
Phone  9823645588  
Fax    
Email  dr.masudaalam10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Masaudaalam Mujawar 
Designation  Professor  
Affiliation  LRP Ayurvedic medical college and hospital, PG Institute and Research institute  
Address  LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur kaumarbhritya department OPD 2 Sangli Maharashtra 415409
LRP Ayurvedic medical college and hospital, PG Institute and Research center Urun Islampur kaumarbhritya department OPD 2 Sangli Maharashtra 415409
Sangli
MAHARASHTRA
415409
India 
Phone  9823645588  
Fax    
Email  dr.masudaalam10@gmail.com  
 
Source of Monetary or Material Support  
LRP Aurvedic medical college and hospital, PG Institute and Research center pediatric opd no 2 Urun Islampur sangli Maharashtra 415409  
 
Primary Sponsor  
Name  Dr Swapnil Devkate 
Address  LRP Aurvedic medical college and hospital, PG Institute and Research center, Urun Islampur 415409 
Type of Sponsor  Other [] 
 
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 Swapnil Bhaskar Devkate  LRP Ayurvedic Medical College and Hospital  LRP Aurvedic medical college and hospital, PG Institute and Research center Urun Islampur Department of kaumarbhritya, OPD 2 Sangli MAHARASHTRA Sangli MAHARASHTRA
Sangli
MAHARASHTRA 		 9970231197

swapnildevkate07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-LRP Ayurvedic Mahavidyalaya   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
1Intervention ArmDrugClassical(1) Medicine Name: Mustakadi Churna, Reference: Bhavprakash samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Patient in age group of 8 to 16 years will be selected irrespective of sex, socioeconomic status and Religion.
Patient suffering from Grahani dosha, symptoms like udarshoola, kshudha alpata, abaddha malpravritti. 
 
ExclusionCriteria 
Details  Children below 8 yrs and above16 yrs.
Children suffering from chronic gastrointestinal disorder And acute infectiou diseases.
Children suffering from the congenital anomalies.
Children with any psychological disorder or any another treatment. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study efficacy of Mustakadi churna in grahani roga.  45 day 
 
Secondary Outcome  
Outcome  TimePoints 
To study the concept of grahani roga in children
To study the etiopathogenesis of Grahani roga related to disease from modern point of view in children. 		 45days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/12/2025 
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 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 - NO
Brief Summary   Childhood is a period In which growth and development are at their
peak.Normally in this period leads to proper growth and development and factors
affecting during this period will not only hamper growth of the child but also it’s
physical activities , social behaviour and immunity concentration.
The Disease “Grahani Dosha” is the leading disorder of gastrointestinal tract.
According to Charaka Aharya ,Grahani is the seat of agni. It is not only seat of
agni but also supported and strengthened by it (i.e. Jatharagni). The term Grahani
dosha implies the malfunctioning of agni. The agni is primarily located in Grahani
(duodenum including upper small part of small intestine). It receives the food (i.e.
Grahan), retains food (i.e. Dharan), till Pachan of ahar (i.e. digestion). While explaining Grahani Dosha, he said that three out of four types of Agnis i.e.Teekshna, Manda,Vishama- may cause Grahani dosha. And if not treated timely then Grahani Roga ensues.Acharya Sushruta has mentioned that, patients of Atisara, during the stage of
Agnimandya, if indulge in injudicious diet, may lead to Grahani Roga. Thus any
disturbance in the functioning of Grahani results in symptoms of indigestion and
is symbolized as Grahani Dosha.
 The lakshana of Grahani roga like udarshool, kshudhaalpata, adhman,
vibandha, abaddhamala pravrutti, shleshmala pravruti, durgandha malapravrutti, balakshaya etc.
 According to Modern Science, Irritable bowel syndrome (IBS) is a group of symptoms that occur together, including repeated pain in your abdomen and changes in your bowel movements, which may be diarrhea, constipation, or both.
With IBS, you have these symptoms without any visible signs of damage or disease in your digestive tract
Primary Objective

To study efficacy of Mustakadi churna in grahani roga.

Secondary objective:

To study the concept of grahani roga in children
To study the etiopathogenesis of Grahani roga related to disease from modern point of view in children.


Study design - Single arm study.

Study setting- patient will be selected randomly from OPD of kaumarbhritya department in our hospital.

Duration of study-18 months.
 Duration of treatment-45days
Sampling method - simple random sampling method
Eligibility criteria:

 Inclusion criteria -

Patient in age group of 8 to 16 years will be selected irrespective of sex, socioeconomic status and Religion.
Patient suffering from Grahani dosha, symptoms like udarshoola, kshudha alpata, abaddha malpravritti.

 Exclusion criteria-

Children below 8 yrs and above16 yrs.
Children suffering from chronic gastrointestinal disorder And acute infectious diseases.
Children suffering from the congenital anomalies.
Children with any psychological disorder or any another treatment.

Withdrawal criteria- Patient will be withdrawl from study if-
Children not on regular follow up.
If any other life threatening symptoms occurs.
Patient or their relative willing to discontinue during treatment.

Diagnostic Criteria-

Patient will be diagnosed on the basis of clinical signs and symptoms of Grahani with respective grading.
 
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