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CTRI Number  CTRI/2023/01/048736 [Registered on: 04/01/2023] Trial Registered Prospectively
Last Modified On: 08/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study the antipyretic effect of Bhadra Mustadi Syrup in school going children  
Scientific Title of Study   An Experimental and a pilot clinical study to evaluate the Jwaraghna (antipyretic) effect of Bhadramustadi Syrup in school going children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAkshay Rathod 
Designation  MD Scholar 
Affiliation  Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 
Address  OPD NO.1 Kaumarbhritya Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  7972204962  
Fax    
Email  akshayrathod2196@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSandip Daberao 
Designation  Associate Professor, Dept. of Kaumarbhritya 
Affiliation  Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 
Address  OPD NO.1 Kaumarbhritya Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  9545402018  
Fax    
Email  dr.deep901@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAkshay Rathod 
Designation  Associate Professor, Dept. of Kaumarbhritya 
Affiliation  Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 
Address  OPD NO.1 Kaumarbhritya Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  7972204962  
Fax    
Email  akshayrathod2196@gmail.com  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 
 
Primary Sponsor  
Name  Dr.Akshay Rathod 
Address  Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018  
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 
DrAkshay Rathod  Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,pimpri,pune 411018  OPD NO.1 Kaumarbhritya Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018
Pune
MAHARASHTRA 		 7972204962

akshayrathod2196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B349||Viral infection, unspecified. Ayurveda Condition: Jwara, (2) ICD-10 Condition:B349||Viral infection, unspecified. Ayurveda Condition: JVARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bhadramustadi syrup, Reference: sharangdhar samhita , Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 1.40(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) children between the age of 6-12 years irrespective of gender and socioeconomic status.
2) children with signs and symptoms of Jwara (fever).
3) children with fever between 37.4 (99.32) to 38.3 (100.94).
4) children suffering from fever for less them 48hr.
5) children whose parents are ready to participate in the clinical trail by giving informed written assent 
 
ExclusionCriteria 
Details  1) children with fever in the range above 38.3 (100.94)
2) children suffer from Fever for more than 48hr.
3) children suffering from the common cold, and cough. vomiting diarrhea fever with rash and other
common conditions.
4) children suffering with major Systemic illness.
5) Patients with history of Febrile Convulsions.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in axillary temperature of patient   5 days study with 0,3rd and 5th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in axillary temperature of patient  5 days study with 0,3rd,5th day follow up 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   01/03/2023 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is single arm study. The aim of study is to observe the antipyretic effect of Bhadramustadi syrup in school going children. Total 12 patients will be enrolled and 1.40ml/kg syrup will be given twice a day after meal. The age group taken for the study is 6 to 12 years of school going children. 
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