| CTRI Number |
CTRI/2024/01/061763 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on Fever patinets |
|
Scientific Title of Study
|
A prospective, interventional, open-label clinical study to evaluate the
safety and efficacy of Febrojith Tablet in the management of pyrexia,
immunomodulatory, anti inflammatory effects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AVP/FJ/001-23 Version 1.0 dated 01 Dec 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AmbrishC |
| Designation |
Principal investigator |
| Affiliation |
Medstar Speciality Hospital |
| Address |
No 641 Medstar Speciality Hospital, Ground floor Room number 2 Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560092
India |
| Phone |
9611934655 |
| Fax |
|
| Email |
ambrishcdr29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sindhu Sreejith |
| Designation |
Vice President-R&D and Technical |
| Affiliation |
The Arya Vaidya Pharmacy (Coimbatore) Ltd |
| Address |
42, Perumal Koil St, Olymbus, Rukmani Nagar,
Ramanathapuram, Coimbatore, Tamil Nadu .
Coimbatore
TAMIL NADU
641045
India |
| Phone |
9446238706 |
| Fax |
|
| Email |
drsindhu@avpayurveda.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhu Sreejith |
| Designation |
Vice President-R&D and Technical |
| Affiliation |
The Arya Vaidya Pharmacy (Coimbatore) Ltd |
| Address |
42, Perumal Koil St, Olymbus, Rukmani Nagar,
Ramanathapuram, Coimbatore, Tamil Nadu .
TAMIL NADU
641045
India |
| Phone |
9446238706 |
| Fax |
|
| Email |
drsindhu@avpayurveda.in |
|
|
Source of Monetary or Material Support
|
| The Arya Vaidya Pharmacy (Coimbatore) Ltd 42, Perumal Koil St, Olymbus, Rukmani Nagar,
Ramanathapuram, Coimbatore, Tamil Nadu 641045 |
|
|
Primary Sponsor
|
| Name |
The Arya Vaidya Pharmacy Coimbatore Ltd |
| Address |
42, Perumal Koil St, Olymbus, Rukmani Nagar, Ramanathapuram, Coimbatore, Tamil Nadu 641045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ambrish C |
Medstar Speciality Hospital |
Medstar Speciality Hospital Ground floor Room number 2
Kodigehalli Main Road Shanthivana Sahakarnagar Bengalurun Karnataka 560092
Bangalore
KARNATAKA |
9611934655
ambrishcdr29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medstar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Febrojith Tablet |
Dosage form: Tablet
Dose:175mg
Duration: 7 days
Age: 2-6 (½ to 1 tablet)-Twice or three times a day
Age:6-18 (1 to 2 tablet)-Twice or three times a day
Age:18 above:2 tablets Twice or three times a day
After food |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 2 to 60 years both male and female.
2.Subject diagnosed with fever (moderate to high grade).
3.Subjects willing and able to provide informed consent voluntarily.
4.Patient is willing and able to comply with all trial requirements. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or Breast feeding.
2.Inability to provide voluntary consent.
3.Volunteers who have participated in any drug research study within past 3 months
4.Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
5.Any clinically significant medical history medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject impact validity of the study results or interfere with the completion of study according to the protocol.
6.History of cancer including solid tumors hematologic malignancies and carcinoma in situ.
7.Use of any anti psychotic drugs in the past.
8.Subjects who abuse drugs or alcohol drug screening not required.
9.Use of any investigational medication within 4 weeks prior to start of study drug.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in fever symptoms from baseline to Day 7 or Day 14 case specific
2.Changes in immune levels from baseline to Day 7 or Day 14 case specific, considering essential blood parameters such as Total Count, Differential Count, and Hb.
3.Changes in inflammatory markers from baseline to Day 7 or Day 14 case-specific. |
Day to Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence and Rate of adverse events from base line to Day 7 or Day 14 case specific.
2.To evaluate consumer acceptance as well as their response toward the product through a feedback questionnaire.
3.To evaluate general well being after medication (such as quality of sleep, craving for food, bowel movements, taste, digestion, and the ability to perform normal activities) |
Day 0 Day 7 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
22/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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/Jvara is a common non-specific symptom experienced by a large number of people and is associated with multiple health conditions. Ayurveda describes fever as Jwara roga. An imbalance between kapha and vata dosha leads to the development of a fever. Jvara is described in Atharvaveda as takman (Son of God Varuna), and drugs like Kustha and Anjana are given to manage this. Various Ayurveda formulations are in practice to limit the fevers of any origi as immune herbs for prevention and curation. Several of these herbs have been extensively studied for their immune-enhancing, modulating and antiviral effects.
Febrojith Tablet consists herbs like Haridra, kirathatiktha, gudoochi,
Vasa, papaya leaves etc, it possess antiviral, anti-infective, anti-pyretic and
enhances immunity. And will helps reduce high temperature, chills and body
aches! AVP Febrojith tablets combine the goodness of natural herbs to support
the body in its fight against infections.
Effectively helps reduce high body temperature
Beneficial in various types of infections
Helps relieve chills and body aches
A powerful blend of proven Ayurveda herbs
Supports immune system functions
The study will be carried out
per the protocol and with principles of the Good Clinical Practice (GCP) i and any regulatory authoritys requirements
|