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CTRI Number  CTRI/2026/01/100562 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Marichadi Gutika and Mandookparni vati in the management of Irritable Bowel Syndrome in Children 
Scientific Title of Study   A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL ON THE EFFICACY OF MARICHADI GUTIKA AND MANDOOKPARNI VATI IN THE MANAGEMENT OF IBS IN CHILDREN 
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 Pooja Singh 
Designation  M D Scholar 
Affiliation  State Ayurvedic college and hospital Lucknow 
Address  P.G. Dept. of Kaumarabhritya OPD NO.1 State Ayurvedic college and hospital, Lucknow Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9935180540  
Fax    
Email  ps636039@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Laxmi 
Designation  Asst. Professor 
Affiliation  State Ayurvedic college and hospital Lucknow 
Address  P.G. Dept. of Kaumarabhritya OPD NO.1 State Ayurvedic college and hospital, Lucknow Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9792446688  
Fax    
Email  lakshmiomsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Laxmi 
Designation  Asst. Professor 
Affiliation  State Ayurvedic college and hospital Lucknow 
Address  P.G. Dept. of Kaumarabhritya OPD NO.1 State Ayurvedic college and hospital, Lucknow Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9792446688  
Fax    
Email  lakshmiomsingh@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital, Turiyaganj, tulsidas marg, Lucknow, Uttar Pradesh Pin code 226004  
 
Primary Sponsor  
Name  State Ayurvedic college and hospital Lucknow 
Address  OPD NO 01 State Ayurvedic College and Hospital Lucknow UTTAR PRADESH 226003 India PG Department of kaumarabhritya State Ayurvedic College and Hospital Tulsidas marg Tudiaganj Lucknow UTTAR PRADESH 226003 India Lucknow UTTAR PRADESH 226003 India  
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 Pooja Singh  State Ayurvedic college and Hospital Lucknow  PG Dept. of kaumarabhritya, State Ayurvedic College and Hospital, Tulsidas marg, Tudiaganj, Lucknow UTTAR PRADESH 226003 India Lucknow UTTAR PRADESH 226003 India
Lucknow
UTTAR PRADESH 		 09935180540

ps636039@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee ,office of institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K909||Intestinal malabsorption, unspecified. Ayurveda Condition: IBS,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Marichadi gutika, Reference: Chakra Datta balrog prakaran 64/42, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: -Gud or Takra), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Mandookparni vati, Reference: Charak chikitsa sthana Ramayan Adhyay 1-3/31, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: Gud or Takra), Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1)patients having age between 6-12yr ,irrespective of sex,religion,occupational and socio-economic status
2)patient having more than or equal to 50% of subjective parameter will be included in the study.
3)Having history of recurrent abdominal pain at least 2 month before diagnosis.
4)History of evacuation after taking meal.
5)patient willing to participate in the research trial. 
 
ExclusionCriteria 
Details  1)Patients having age below 6 year and above 12year.
2)Red Flag in Diagnosing IBS
-Confirmed weight loss
-Symptoms persistent or worse at night (child wakes up with pain)
-Unexplained anemia
-Bleeding per rectum.
-Severe diarrhea and/or vomiting
-Unexplained fever
-Strong family history of inflammatory bowel disease
3)Children having already history of metabolic disorders and systemic disorder like TB, DM etc. will be excluded from the study.
4)Children suffering from congenital anomalies, acute infectious disease

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Improvement in condition of children.
2) Improvement frequency/consistency of stool in 15 days of trial.
3)Improvement in abdominal pain.

 		 after 15th days of complete clinical trial 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of marichadi gutika and mandookparni vati  After completing the 15th day of trial 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 1 
Date of First Enrollment (India)   15/02/2026 
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="2"
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 - NO
Brief Summary  
This study is a double blind randomized clinical trial planned to evaluate the efficacy of Marichadi Gutika and Mandookparni Vati in the management of Irritable Bowel Syndrome in children. Irritable Bowel Syndrome is a common functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits without any structural abnormality. It significantly affects the physical growth emotional wellbeing and quality of life of children. Modern medicine mainly focuses on symptomatic relief whereas Ayurveda explains this condition under the concept of Grahani Roga which occurs due to impairment of digestive fire influenced by improper diet lifestyle and mental stress.

The trial will be conducted on children aged six to twelve years diagnosed with Irritable Bowel Syndrome according to Rome Four criteria. A total of sixty patients will be randomly divided into two groups receiving either Marichadi Gutika or Mandookparni Vati for a period of seventy five days. Both medicines are selected for their digestive stimulant bowel regulating and mind calming properties. Regular follow up and assessment will be done based on clinical symptoms such as abdominal pain bowel irregularity appetite and general weakness. 
The study aims to provide scientific evidence for the effectiveness and safety of Ayurvedic formulations in managing Irritable Bowel Syndrome in children and to improve their overall quality of life through a holistic approach.
 
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