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CTRI Number  CTRI/2026/02/103802 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ketaki Sarkara Syrup in the Management of Krimi in Children  
Scientific Title of Study   An Open Labelled Randomized Controlled Clinical to Evaluate The Effect of Ketaki Sarkara Syrup in the Management of Krimi (Worm Infestation) 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  Mohit Yadav 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved and Research 
Address  Department of kaumarabhritya parul institute of ayurved and research, Parul University Limda, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  8999615301  
Fax    
Email  mohityadav20998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Raj GR 
Designation  HOD & Professor 
Affiliation  Parul Institute of Ayurved and Research 
Address  Department of kaumarabhritya parul institute of ayurved and research, Parul University Limda, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9886292826  
Fax    
Email  drdrarunraj26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Raj GR 
Designation  HOD & Professor 
Affiliation  Parul Institute of Ayurved and Research 
Address  Department of kaumarabhritya parul institute of ayurved and research, Parul University Limda, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9886292826  
Fax    
Email  drdrarunraj26@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mohit Yadav 
Address  Post graduate scholar,Department of Kaumarabhritya, Parul University, Vadodara-391760, Gujarat 
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 Mohit Yadav  Khemdas Hospital  OPD No 6,Ground Floor,Parul Institute Of Ayurved And Research, Parul University, Vadodara-391760, Gujarat
Vadodara
GUJARAT 		 8999615301

mohityadav20998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee IEC-PIAR HR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B820||Intestinal helminthiasis, unspecified. Ayurveda Condition: KRUMIH/SANJATAKRUMI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ketaki Sarkara, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugOther than Classical(1) Medicine Name: Wormicid plus Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Children in the age group of 5-10 years fulfilling diagnostic criteria will be registered for the trial.
2. Children whose parents are willing to participate in the study after giving written consent. 
 
ExclusionCriteria 
Details  1. Acute symptoms like acute abdominal pain, severe diarrhea, severe vomiting, and fever (above 100°F).
2. Any congenital gastrointestinal anomalies, like intestinal obstruction.
3. Children diagnosed with Intestinal complications like Appendicitis, Acute abdomen, Pyloric stenosis, and Meckel’s diverticulum.
4. Children suffering from severe malnutrition.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of Ketaki Sarkara syrup in reducing the classical symptoms of Krimi Roga in children compared to Wormicid syrup  0th day, 8th day and 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess parasitological clearance through stool examination, monitor safety and tolerability by observing adverse drug reactions, and compare overall therapeutic effectiveness between the two formulations.  0th day and 15 day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   01/05/2026 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mohityadav20998@gmail.com].

  6. For how long will this data be available start date provided 30-09-2027 and end date provided 30-09-2028?
    Response (Others) -  One year of post publication of research

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is an open-label, randomized controlled clinical trial designed to evaluate and compare the clinical efficacy and safety of Ketaki Sarkara syrup with Wormicid Plus syrup in the management of Krimi Roga (intestinal worm infestation) in children aged 5–10 years. Diagnosed cases will be selected based on classical Ayurvedic symptoms and confirmed by microscopic stool examination. The intervention will be administered for 15 days, and outcomes will be assessed through improvement in clinical symptoms, parasitological clearance, and monitoring of adverse drug reactions. The study aims to scientifically validate Ketaki Sarkara syrup as an effective and safe Ayurvedic alternative for pediatric worm infestation 
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