| CTRI Number |
CTRI/2022/04/041681 [Registered on: 06/04/2022] Trial Registered Prospectively |
| Last Modified On: |
04/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to see the effect of Febrikid Suspension in Fever in children.
|
|
Scientific Title of Study
|
A single arm clinical study to evaluate the antipyretic
effect Of Febrikid Suspension 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 Aruna Kumari Sangwan |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD-103,Parul Ayurveda Hospital, Kaumarbhritya Department, Parul Institute of Ayurveda, Parul University,Post-Limda,Vadodara,Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8708763385 |
| Fax |
|
| Email |
arunasangwan94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Kumar Pani |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD-103,Parul Ayurveda Hospital, Kaumarbhritya Department, Parul Institute of Ayurveda, Parul University,Post-Limda,Vadodara,Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9408707703 |
| Fax |
|
| Email |
drsudhirpani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Kumar Pani |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD-103,Parul Ayurveda Hospital, Kaumarbhritya Department, Parul Institute of Ayurveda, Parul University,Post-Limda,Vadodara,Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9408707703 |
| Fax |
|
| Email |
drsudhirpani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurveda,Parul University,Limda,Vadodara,Gujarat-391760 |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarbhritya |
| Address |
Parul Institute of Ayurveda,Parul University,Post-Limda,Vadodara,Gujarat |
| Type of Sponsor |
Private medical college |
|
|
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 Aruna Kumari Sangwan |
Parul Institute of Ayurveda |
OPD-103,Parul Ayurveda Hospital, Kaumarbhritya Department, Parul Institute of Ayurveda, Parul University, Post-Limda, Vadodara
Vadodara
GUJARAT |
8708763385
arunasangwan94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 suspension, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 20(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of either gender suffering from fever of age 3-10 years.
2. Acute onset of fever of 1 to 3 days.
3. Temperature between 99-102 Fahrenheit.
4. Children with parents who agree to participate and sign the informed consent. |
|
| ExclusionCriteria |
| Details |
1. Fever more than 102 Fahrenheit.
2. Chronic fever associated with infective disorder.
3. Fever more than 3 days and diagnosed with malaria, dengue, typhoid, pneumonia etc.
4. 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 as non induceable 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 |
| Relief in Fever |
5 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in associated symptoms of Fever according to Ayurveda Classics everyday. |
5 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/04/2022 |
| Date of Study Completion (India) |
17/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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 a symptom of other underlying disease.
Fever is one of the most common presenting signs of illness in office-based pediatric
practice, and is present in 19% to 30% of encounters. There are on average 8 visits for fever per
child per year, one quarter of which are for fever 39°C, is a lower bound of the actual rate. Fever
in children is one of the most common manifestations of illness, which makes the parents to seek
medical attention early. Fever occurs when various infectious and non-infectious processes interact
with the host’s defense mechanism.
Because of immature immune system of children, they are more prone to infections in
which fever is one of the symptoms. Fever is most commonly associated with self-limited viral
illness, but may be the presenting feature of occult bacteremia which, untreated, can lead to
meningitis or other serious sequel.
4Hence it is obligatory to control fever in early stage.
Fever is the commonest presentation of many diseases of childhood and is of very primary or of
utmost concern as children may have chances to get febrile convulsion as one of the deadly
complication of fever in paediatric age group. Considering this early intervention for fever in
children is highly essential.
|