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CTRI Number  CTRI/2025/03/082607 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Krishnadi yog in abdominal pain  
Scientific Title of Study   A Double Blind Placebo Controlled Clinical Trial On Krishnadi Yog In Functional Abdominal Pain (FAP) Of School Age 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 Ankit Pal  
Designation  MD 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  8318259044  
Fax    
Email  ankitpal131@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, Lucknow,226003 
 
Primary Sponsor  
Name  State ayurvedic college and hospital Lucknow 
Address  Tulsidas marg, old Haiderganj,Lucknow 
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 Ankit pal  State ayurvedic College and hospital Lucknow  PG Department of Kaumarabhritya OPD no-1 Tulsidas Marg, Lucknow, UttarPradesh, India
Lucknow
UTTAR PRADESH 		 8318259044

Ankitpal131@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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:K929||Disease of digestive system, unspecified. Ayurveda Condition: AJIRNAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Mishri vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Dadhi mastu), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Krishnadi yoga, Reference: Kumaratantrama, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Dadhi mastu), Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between 6-12 yr of age irrespective of sex, religion, occupational and
socio-economic status.
Children fulfilling ROME IV Criteria.
Patient have pain at least once per week for more/equal 2 month.
Patient willing to participate in the research trial. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To improve quality of life in school going children.  At 75 day of completing clinical trial. 
 
Secondary Outcome  
Outcome  TimePoints 
To access efficacy of KRISHNADI YOG with the anupan of Dadhi Mastu in management of Functional Abdominal Pain  15th, 30th, 45th, 60th days of During trial. And 30th day of after trial. 
 
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)   09/04/2025 
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="2"
Days="15" 
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   Functional abdominal pain is one of the lifestyle disorders.To improve the quality of life suffering from functional abdominal pain therefore I selected this clinical trial. Clinical trial will be done on Krishnadi yoga . Maximum 40 Functional constipation diagnosed children aged 6-12 yr clinical studies into two group of treatment modules. Each segment of the treatment module will be of 2 months after each treatment there is a gap of 30 days Total duration of trial is 90 days. Follow up will be performed before intervention and after 15 days of each treatment module . A follow up will be done after 30 days of complete clinical trial. 
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