| CTRI Number |
CTRI/2022/03/041337 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Antipyretic effect of Ayurveda compound on fever in children |
|
Scientific Title of Study
|
A single arm clinical trial to evaluate the antipyretic effect of febrikid tablets in febrile children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Detroja |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room Number 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Limda Vadodara
Room Number 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
shraddhadetroja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil C Raskar |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room Number 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
neonatecare99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Detroja |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room Number 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
shraddhadetroja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved Parul University Vadodara Gujarat India |
|
|
Primary Sponsor
|
| Name |
Dr Shraddha Detroja |
| Address |
Room No 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Limda Vadodara Gujarat India 391760 |
| 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 |
| Dr Shraddha Detroja |
Parul Ayurveda Hospital |
Room Number 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Limda Vadodara
Vadodara
GUJARAT |
9265777066
shraddhadetroja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B999||Unspecified infectious disease. Ayurveda Condition: JVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Febrikid Tablet, Reference: NA, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient of either gender suffering from fever of age 5 to 12 years
2) Acute onset fever of 1 to 3 days
3) Temperature between 99 to 103 Fahrenheit
4) Children with parents who agree to participate and sign the informed consent
|
|
| ExclusionCriteria |
| Details |
1) Fever more than 103 Fahrenheit
2) Any febrile condition of children requiring an immediate intervention depending on history and general condition at the point of examination as found by the investigator will be excluded from study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Fever and body temperature
Reduction in body ache and headache
improvement in appetite |
At base line
On Day 2
Day 3
Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in Leg cramps
Improvement in weakness |
5 days
7 days
10 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/04/2022 |
| 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="0"
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 trial is designed to evaluate the efficacy of Ayurveda Antipyretic for children As there is need of hour to develop the Ayurveda antipyretic drug which act quickly |