| CTRI Number |
CTRI/2023/01/048744 [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
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the antipyretic effect of Kiratadi Syrup in school going children |
|
Scientific Title of Study
|
An Experimental and a pilot clinical study to evaluate the Jwaraghna(antipyretic) effect of Kiratadi 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 |
DrShivpratap Biradar |
| 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 |
7517042105 |
| Fax |
|
| Email |
biradarshivpratap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAboli Patil |
| 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 |
9422783313 |
| Fax |
|
| Email |
drabolipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAboli Patil |
| 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 |
9422783313 |
| Fax |
|
| Email |
drabolipatil@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.Shivpratap Biradar |
| 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShivpratp Biradar |
Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,pimpri,pune 411018 |
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018
Pune
MAHARASHTRA |
7517042105
biradarshivpratap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B349||Viral infection, unspecified. Ayurveda Condition: JVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KIRATADI , Reference: GADANIGRAH, 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(99.3â°f)to 38.3â°c(100.94â°f)
4)children suffering from fever for less than 48hr.
5)Children whose parents are ready to participate in the clinical trial by giving informed written assent.
|
|
| ExclusionCriteria |
| Details |
1)Children with fever >38.3â°C(100.94â°F)
2)Children suffer from Fever for more than 48hr.
3)Children suffering from the common cold, and cough. Vomiting diarrhea fever with rash and the common conditions
4)K/C/O 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 the patients |
5 days study with 0,3rd and 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of Kiratadi Syrup |
5 days study with 0,3rd and 5th day |
|
|
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)
|
15/03/2023 |
| 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 Kiratadi Syrup in school going children.Total 12 patient will be enrolled and 1.40ml/kg syrup will be given in divided doses thrice in a day after meal. The age group taken for the study is 6 to 12 years of school going children. |