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CTRI Number  CTRI/2025/08/093290 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
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   Comparison of an Ayurvedic Polyherbal Syrup and Ondansetron Syrup for Vomiting (Chhardi) in Children of 1 year to 18 years 
Scientific Title of Study   Evaluation of the comparative efficacy of Polyherbal syrup versus Ondansetron syrup in the management of Chhardi(vomiting) in children: A Randomized Controlled Trial 
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 DHANANJAY BHAGWAN MORE 
Designation  PG SCHOLAR 
Affiliation  Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha 
Address  Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha MAHARASHTRA 442001 India Wardha MAHARASHTRA

Wardha
MAHARASHTRA
442001
India 
Phone  8956125085  
Fax    
Email  moredhananjay002@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RENU B RATHI 
Designation  PROFESSOR AND HOD 
Affiliation  Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha 
Address  Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha MAHARASHTRA 442001 India Wardha MAHARASHTRA

Wardha
MAHARASHTRA
442001
India 
Phone  9011058302  
Fax    
Email  rbr.226@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR DHANANJAY BHAGWAN MORE 
Designation  PG SCHOLAR 
Affiliation  Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha 
Address  Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha MAHARASHTRA 442001 India Wardha MAHARASHTRA

Wardha
MAHARASHTRA
442001
India 
Phone  8956125085  
Fax    
Email  moredhananjay002@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod, Hirapur, Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurved College, Hospital and Research Centre 
Address  Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha. MAHARASHTRA 442001 India Wardha MAHARASHTRA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 DHANANJAY BHAGWAN MORE  Mahatma Gandhi Ayurved College, Hospital and Research Centre  Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha. MAHARASHTRA 442001 India Wardha MAHARASHTRA
Wardha
MAHARASHTRA 		 8956125085

moredhananjay002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R111||Vomiting. Ayurveda Condition: CARDIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Polyherbal Syrup, Reference: 1) Priyangwadi Kalka Referance-Bhaishajya Ratnavali Chapter 71/46 2) Shunthi Referance- Bhavprakash Nighantu Haritakyadi Varga 3) Ela Referance- Bhavprakash Nighantu Karpuradi Varga, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: In the formulation of a polyherbal syrup, I have incorporated Priyangwadi Kalka as described in Bhaishajya Ratnavali, Chapter 71, verse 46, for the treatment of Chhardi (vomiting) in children, To enhance the antiemetic effect of this Kalka, I have added Shunthi and Ela, both of which are referenced for their antiemetic properties in Bhavaprakash Nighantu—Shunthi under the Haritakyadi Varga and Ela under the Karpuradi Varga
2Comparator Arm (Non Ayurveda)-Ondansetron SyrupOndansetron is a selective 5-HT₃ receptor antagonist. Mechanism of action: It works by blocking serotonin receptors (5-HT₃) in both the central nervous system and the gastrointestinal (GI) tract, which prevents the transmission of signals that cause nausea and vomiting. In the GI tract, serotonin release during chemotherapy, radiation, or other stimuli triggers vomiting. Ondansetron prevents this action by inhibiting serotonin’s interaction with its 5-HT₃ receptor. – In the brain, it blocks the chemoreceptor trigger zone (CTZ), which helps to reduce nausea and vomiting.
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1)Written informed Consent and ascent will be obtain
2)Age 1 year to 18 years
3)3 or more than 3 episodes of vomiting in 24 hours
4)Mild to moderate dehydration
5)Associated diarrhea patients will also be included 
 
ExclusionCriteria 
Details  1)Moderate to Severe infection and dehydration or shock
2)Any Chronic systemic illness
3)Antiemetic use in the past 24 hours
4)Allergy to any formulation ingredient
5)Fever more than 100 degree fahrenheit
6)Abuse, poison or suspicious case
7)Congenital anomalies and Metabolic syndrome
8)Participants did not receive the Antihelminthic drug  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Polyherbal Syrup in the management of chhardi in children of age 1 year to 18 years with objective and subjective criteria   Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and
14th day  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of Ondansetron Syrup in the management of chhardi in children with objective and subjective criteria.   Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and
14th day  
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/10/2025 
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="2"
Months="0"
Days="0" 
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    The volunteers will be informed about the study protocol. Willing participants will be randomly selected from per computer-generated table. The clinical research format will be prepared and validated. Before the study approval is taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a Randomized, double-blind, equivalence  Clinical Trial. Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and 14th day. 
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