| CTRI Number |
CTRI/2024/02/063022 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of fevogrit in treatment of fever |
|
Scientific Title of Study
|
A clinical study on efficacy of fevogrit in treatment of fever A single arm open label observational study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C B Dhanraj |
| Designation |
Dean of PG Studies |
| Affiliation |
Patanjali Ayurved Hospital Patnjali Yogpeeth (Trust) |
| Address |
Department of Kayachikitsa
3nd floor, Room No.: 403 Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar (Uttarakhand)
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7396174582 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C B Dhanraj |
| Designation |
Dean of PG Studies |
| Affiliation |
Patanjali Ayurved Hospital Patnjali Yogpeeth (Trust) |
| Address |
Department of Kayachikitsa
3nd floor, Room No.: 403 Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar (Uttarakhand)
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7396174582 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Rauthan |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjlai Reseach Foundation |
| Address |
Clinical Research Division
2nd floor, Drug Discovery & Development Division (D4 Building)
Opp. Patanjali Yogpeeth-1 Dayanand Gram, Delhi-Haridwar National Highway, Near Bahadrabad, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7217049394 |
| Fax |
|
| Email |
pratibha@patanjali.res.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation |
|
|
Primary Sponsor
|
| Name |
Patanjlai Research Foundation |
| Address |
Opp Paranjali Yofpeeth 1 Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 |
| 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 |
| Dr C B Dhanraj |
Patanjali Ayurved Hospital |
Divya Yoga Trust, Department of Kayachikitsa, Bahardrabad Haridwar (Uttarakhand) Pin code: 249405
Hardwar
UTTARANCHAL |
7396174582
drcbdhanraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R509||Fever, unspecified. Ayurveda Condition: JVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both gender with age limit 18 to 60 years
Body temperature more than 99°F (37.2°C)
Willing to participate and give consent for the study |
|
| ExclusionCriteria |
| Details |
Subject on antipyretic, antibiotic, and steroidal medication within the previous 8-12 hours
Any acute or chronic condition that would limit the ability of the patient to participate in the study (Renal, Cardiac disease, Liver disease, or hematologic disorders, bronchial asthma, peptic ulcer disease, and frequent vomiting)
Any condition the investigator identifies that can confound the participants ability to properly participate in the study
Pregnancy or lactation, intention to pregnancy
Known case of Hypothyroidism & Endocrine disease condition.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in fever in the first four hours after the first dose of fevogrit |
Baseline 1hr 2hr 3hr 4hr 8hr
Day 2
Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
First occurrence of normal temperature
|
Day 1
Day 2
Day 3 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be observational, prospective and open label to evaluate the changes in temperature of the patient who will be taking Fevogrit as prescribed by Ayurvedic practitioner. Eligible patient based on the inclusion criteria, will be assessed for their time without fever (<37.2°C) in the first four hours after the first dose of Fevogrit and the time of first occurrence of normal temperature (fever clearance), time without fever over 24 hours of enrolment. The primary outcome measure in this study will be the reduction in body temperature after treatment. It will be initially measured and compared on hourly basis and later at progressively larger intervals. The body temperature will be measured orally by means of a standard doctor’s thermometer in 0F at the start of the treatment and on hourly basis during the first 4 h. It will be taken at 4 h intervals during the next 8 h, at 6 h intervals during the subsequent 12 h and at 12 h intervals for the next 2 days. In addition to the temperature measurement, the patients and their attendants will be given elaborate instructions to measure the patients’ body temperature and record the same in a patient diary card for fever supplied to them |