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CTRI Number  CTRI/2025/03/083538 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 02/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Random Study on Bilvadi kwath (Divitya) in the management of acute watery diarrhoea-a clinical study 
Scientific Title of Study   A randomized Clinical Comparative study to Evaluate the Efficacy of Bilvadi Kwath (Divitya)and O.R.S.in the management of Atisara (Acute watery diarrhea)in children.  
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikash 
Designation  Assistant Professor 
Affiliation  Gaur Brahman Ayurvedic Medical college,Brahmanwas 
Address  O.P.D.NO. 5, GROUND FLOOR, BALROG DEPARTMENT,GAUR BRAHMAN AYURVEDIC MEDICAL COLLEGE,BRAHMANWAS,ROHTAK
Opd no. 5 ,balrog dept.gaur brahmin ayurvedic medical College,brahmanwas
Rohtak
HARYANA
124001
India 
Phone  7777010771  
Fax    
Email  vickykaushik19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Amit Kataria 
Designation  Associate Professor 
Affiliation  Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Kurukshetra (Haryana), 
Address  PG Deptt. of Kaumarbhritya Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Kurukshetra (Haryana), Pin-136118
IASR,SKAU,KURUKSHETRA
Kurukshetra
HARYANA
136118
India 
Phone  9034001230  
Fax    
Email  dramitkataria@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Vikash 
Designation  Assistant Professor 
Affiliation  Gaur Brahman Ayurvedic Medical college,Brahmanwas 
Address  O.P.D.NO. 5, GROUND FLOOR, BALROG DEPARTMENT,GAUR BRAHMAN AYURVEDIC MEDICAL COLLEGE,BRAHMANWAS,ROHTAK
Balrog dept. Gaur brahmin ayurvedic medical College brahmanwas
Rohtak
HARYANA
124001
India 
Phone  7777010771  
Fax    
Email  vickykaushik19@gmail.com  
 
Source of Monetary or Material Support  
Prepared from GMP certified company , from India .124001 {Haryana} 
 
Primary Sponsor  
Name  VIKASH 
Address  BALROG DEPT.,GAUR BRAHMAN AYURVEDIC MEDICAL COLLEGE, brahmanwas,124001. Haryana, India 
Type of Sponsor  Other [NIL] 
 
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 VIKASH  GAUR BRAHMAN AYURVEDIC MEDICAL COLLEGE, BRAHMANWAS,ROHTAK  Opd no. 5 ,Balrog department ,G.B.A.C.,BRAHMANWAS, ROHTAK,Haryana,124001
Rohtak
HARYANA 		 7777010771

vickykaushik19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SKAU,KURUKSHETRA  Approved 
university research committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K598||Other specified functional intestinal disorders. Ayurveda Condition: ATISARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-O.R.S.oral rehydration solution
2Intervention ArmDrugClassical(1) Medicine Name: Bilvadi kwath{Divitya}, Reference: Chakradatta 64/35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 3(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -medicine dose will be decided as per body weight
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  age - 2-10yrs.
degree of dehydration -mild
patients having Atisara only of recent origin.
duration :less than 7days.
irrespective of socio-economic status. 
 
ExclusionCriteria 
Details  patients having below 2yrs and 10 yrs above.
patients having Atisara due to iatrogenic origin.
patients having chronic atisara.
patients having occult and fresh blood in stool/intussusception/dysentry.
patients with mild and severe degree of dehydration. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
patient will get relief in episodes of Atisara  Within 3 days of follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Also decreases chardi  Within 15 days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 2/ Phase 3 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 01 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   It is a randomized clinical study which is conducted on patients having  mild Atisara and their management will be done with Bilvadi Kwath (Divitya ) as trial group and O.R.S. as controlled group.total duration of study is 10 days.  
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