| CTRI Number |
CTRI/2023/07/055248 [Registered on: 14/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to Evaluate antipyretic effect of Febrikid plus tablet in Children |
|
Scientific Title of Study
|
A Randomized Controlled Clinical study to evaluate the antipyretic effect of Febrikid Plus Tablets in children with febrile state. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailaja Lohar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Kaumarbhritya OPD NO 103 and IPD, Parul Ayurveda Hospital, Parul University, Limbda, Vadodara , Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
7588118408 |
| Fax |
|
| Email |
shailajalohar269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Raskar |
| Designation |
Associate Professor |
| Affiliation |
Parul Institue of Ayurveda |
| Address |
Kaumarbhritya OPD NO 103 and IPD, Parul Ayurveda Hospital, Parul University, Limbda, Vadodara , Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
neonatecare22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipeeka Surwase |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Kaumarbhritya OPD NO 103 and IPD, Parul Ayurveda Hospital, Parul University, Limbda, Vadodara , Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9860750957 |
| Fax |
|
| Email |
drdipeeka77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kaumarbhritya OPD NO 103 and IPD, Parul Ayurveda Hospital, Parul University, Limbda, Vadodara , Gujarat 391760 India |
|
|
Primary Sponsor
|
| Name |
Parul Ayurveda Hospital |
| Address |
Kaumarbhritya OPD NO 103 and IPD, Parul Ayurveda Hospital, Parul University, Limbda, Vadodara , Gujarat 391760 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shailaja kishanrao Lohar |
Parul Ayurveda Hospital |
Kaumarbhritya OPD NO 103 and IPD, Parul Ayurveda Hospital, Parul University, Limbda, Vadodara , Gujarat 391760 India
Vadodara
GUJARAT |
7588118408
shailajalohar269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITUTION ETHICS COMMITEE FOR HUMAN RESEARCH |
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 PLus, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -jala or madhu), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | PCM(Paracetamol) | paracetamol
dose and duration as per recommended by physician
route - oral |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Temperature between 99- 103 oF.
2.Fever of acute onset without any complications i.e. dehydration, convulsion, etc.
3.Acute onset fever of 1 to 3 days.
4.Patient of either sex suffering from fever of age 3-12 years.
5.Children with parents who agree to participate and sign the informed consent
|
|
| ExclusionCriteria |
| Details |
1.Fever more than 3 days.
2.Chronic fever (> 5 days) associated with poor hemodynamic and clinical outcomes.
3.Any febrile condition of children requiring an immediate intervention depending of history and general condition at the point of examination as found by the investigators non inducible was be excluded from study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced in Fever & Body Temerature
Reduced in Body ache & headache
Improvement in appetite |
At baseline
On Day 2
Day 3
Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Leg cramps
Improvement in Weakness
Reduced Irritability |
4 days
5 days
6 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fever
is very primary clinical feature of most of illnesses and it is very primary
sign that lead to individual for seeking the medical aid and forcing the
physician to investigate the case. Ranging from the simplest
common cold to severe most carcinomatous situation, fever is the important sign
which can’t be ignored. Fever
causes the feeling of uneasiness and discomfort, along with loss of appetite,
tastelessness, irritability as its cardinal subjective feeling.
Apart
from this increase in body temperature is alarming physiological sign which
should be taken in account on priority basis.
Therefore,
to reduce the body temperature is the main aim of therapy while treating fever
as disease or fever as symptom of other underlying disease.
Reduction
in body temperature is achieved with different mean in Allopathic medicine
aiming mainly as antipyretic effect. Paracetamol, Ibuprofen, mefenamic acid,
diclofenac sodium are different antipyretics are in used since long time, and
this entire agent are found to be effective and safe in recommended doses.
Though
this agent reduces the body temperature readily, in many cases there is no
effect of antipyretic
pharmacological agent on pathology of underlying diseases and hence these drugs
have only role in symptomatic relief of body temperature, pain etc.
This Trial is designed to evaluate the efficacy of Ayurveda Antipyretic for Children . As to develop the ayurveda antipyretic drug which acts quickly on symptom and as well on its pathology. |