CTRI/2024/12/077666 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On:
04/12/2024
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To Assess the Safety, Tolerability and Efficacy of Inosine Pranobex Tablets in Patients with Influenza and Other Acute Respiratory Viral Infections.
Scientific Title of Study
A Phase IV, Prospective, Multi-centre, Open label, Randomized Two-Arm Study to Assess the Safety, Tolerability and Efficacy of Inosine Pranobex 500 and 1000 mg Tablets Manufactured by Themis Medicare Ltd in Patients with Influenza and Other Acute Respiratory Viral Infections.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
TML/IAD/05, Version 01, Dated 06 October 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Balaji More
Designation
Vice President - Medical
Affiliation
Themis Medicare Limited
Address
11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India. 11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India. Mumbai MAHARASHTRA 400104 India
Phone
8452959225
Fax
Email
balaji.more@themismedicare.com
Details of Contact Person Scientific Query
Name
Dr Balaji More
Designation
Vice President - Medical
Affiliation
Themis Medicare Limited
Address
11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India
11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India Mumbai MAHARASHTRA 400104 India
Phone
8452959225
Fax
Email
balaji.more@themismedicare.com
Details of Contact Person Public Query
Name
Dr Balaji More
Designation
Vice President - Medical
Affiliation
Themis Medicare Limited
Address
11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India 11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India Mumbai MAHARASHTRA 400104 India
Phone
8452959225
Fax
Email
balaji.more@themismedicare.com
Source of Monetary or Material Support
Themis Medicare Limited, 11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India.
Primary Sponsor
Name
Themis Medicare Limited
Address
11/12 Udyog Nagar, Goregaon (West),Mumbai-400104, Maharashtra, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 5
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Dilip Kadam
Care Multispeciality Hospital
Department of General Medicine, Care Multispecialty Hospital, Kotle Arcade, Pune- Nagar Road ,Wagholi,Pune-412207, Maharashtra, India. Pune MAHARASHTRA
7066115411
dr.dilipkadam12@gmail.com
Dr Biswaroop Mukherjee
Kasturi Das Memorial Superspeciality Hospital
Department of General Medicine, Kasturi Das Memorial Superspeciality Hospital, A Unit of Dishari Health Point Pvt Ltd Holding No. - B1-38/1/New Santoshpur, Block-B, Road Bye Lane -1, P.O. - Santoshpur (M), P.S. - Maheshtala, Kolkata 700142, India. Kolkata WEST BENGAL
Department of Internal Medicine, Medigene Multispeciality Hospital Private limited (Akshaya Hospital), D.No.43-9-201, Sy No.321-323, Railway New Colony, Visakhapatnam-530016, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
9440122790
drgopalraoa@gmail.com
Dr Nutan Agrawal
MLB Medical College and Hospital
Department of General Medicine, MLB Medical College and Hospital, Kanpur Road, Jhansi-284128, Uttar Pradesh, India. Jhansi UTTAR PRADESH
9839789378
dr_nutan_agrawal@yahoo.com
Dr Suresh Raparthy
St. Ann’s Cancer and General Hospital
Department of Pulmonary Medicine, St. Ann’s Cancer and General Hospital, 24-7-5, Fathima Nagar, Darga Kzp Road, Kazipet, Hanamkonda, Telangana 506004, India. Warangal TELANGANA
9963060098
drsuresh.krcwgl@gmail.com
Details of Ethics Committee
No of Ethics Committees= 5
Name of Committee
Approval Status
Care Multispeciality Hospital, Institutional Ethics Committee, Kotle Arcade, Pune- Nagar Road ,Wagholi,Pune-412207, Maharashtra, India
Approved
Ethics Committee , MLB Medical College and Associated Hospital,Kanpur Road, Jhansi-(UP)284128
Approved
Institutional Ethics Committee Medigene Multispeciality Hospital Private Limited D.No.43-9-201, Sy No.321-323 Railway New Colony, Visakhapatnam Visakhapatnam Visakhapatnam Andhra Pradesh - 530016 India
Approved
Institutional Ethics Committee,Kasturi Das Memorial Superspeciality Hospital, A Unit of Dishari Health Point Pvt Ltd Holding No. - B1-38/1/New Santoshpur, Block-B, Road Bye Lane -1, P.O. - Santoshpur (M), P.S. - Maheshtala, Kolkata 700142.
Viralex® (Inosine Pranobex 1000 mg tablets), Route: Oral. Frequency: Two times daily for 7 days.
Intervention
Viralex® (Inosine Pranobex)
Viralex® (Inosine Pranobex 500 mg tablets),
Route: Oral.
Frequency: Three times daily for 7 days.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or Female subjects greater than or equal to 12 to less than or equal to 65 years of age presenting with clinical signs and symptoms indicating influenza and or other acute respiratory viral infections.
Signs and symptoms of influenza can include some or all of these symptoms: fever or feeling feverish, chills, cough, sore throat, runny or stuffy nose, muscle or body aches, headache, fatigue (tiredness), and sometimes diarrhoea or vomiting.
Signs and symptoms of acute respiratory viral infections: Body temperature greater than or equal to 100 degree Fahrenheit, plus or minus At least one respiratory symptom (cough, sore throat, or nasal obstruction) plus or minus At least one constitutional symptom (fatigue, headache, myalgia, or feverishness)
2. Agreeing to provide informed consent (by the parents or legally acceptable or authorized representative (LAR) and assent (written assent for 12 to 17 year old children), as required, prior to study enrolment and to comply with study procedures
3. Subjects agreeing not to participate in another clinical trial during the study period.
4. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
5. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 28.
ExclusionCriteria
Details
1. Subjects with known hypersensitivity to any of the ingredients of the Inosine Pranobex.
2. Subject with a history of gout or hyperuricemia (serum uric acid level greater than 8 mg per dl).
3. Subjects with signs, symptoms or having laboratory results suggestive of bacterial etiology.
4. Subject requiring mechanical ventilation or extracorporeal membrane oxygenation at screening.
5. Subjects who are undergoing treatment with xanthine oxidase inhibitors (allopurinol) or uricosuric agents or treatment with thiazide (for example hydrochlorothiazide, chlorthalidone, and indapamide) or loop diuretics (for example furosemide, torsemide, and ethacrynic acid).
6. Subject with a history of renal or hepatic impairment.
7. Any subject who had received more than 1 dose of influenza antiviral medication (for example, oseltamivir or zanamivir), or any dose of ribavirin within 2 weeks, prior to the first study drug intake, or received intravenous peramivir greater than 1 day prior to screening.
8. Subjects with any serious disease condition or disorder that in the opinion of the investigator should preclude participation.
9. Female subjects with known pregnancy or actively breastfeeding.
10. Subjects with exacerbated or decompensated chronic diseases affecting the participants ability to participate in the clinical trial.
11. Subjects with malabsorption syndrome, including congenital or acquired conditions.
12. Subjects with a history of bronchial asthma.
13. Subjects with a history of convulsion or epilepsy.
14. Subjects with severe decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the subjects prognosis, and make him or her ineligible for the clinical study).
15. Subjects with compromised hepatic or renal function, as shown by but not limited to baseline AST or ALT 3 times the upper limit of the normal range, serum creatinine greater than or equal 2.0 mg per dl and or BUN greater than or equal 30 mg per dl, respectively.
16. Subjects with a history of oncological diseases, HIV, tuberculosis.
17. Subjects who received antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
18. Subjects having difficulty in dosing or consuming the oral medication or with any condition, which in the opinion of the investigators makes the subject unsuitable for inclusion.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The proportion of subjects reporting treatment-emergent AEs (TEAEs) at EOS.
Day 10, End of Study
Secondary Outcome
Outcome
TimePoints
1. The proportion of subjects reporting SAEs at End of the study
2. Tolerability and efficacy on clinical Global Impression Scale
3. The time to resolution of all influenza-like symptoms present at baseline to none (i.e., a score of 0, defined as the complete absence of symptoms, on the influenza-like symptoms assessment scale)
4. Time to resolution of respiratory symptoms (cough, sore throat, and nasal obstruction); time to absence of fever (oral temperature of ≤99.5°F for at least 2 consecutive readings that were at least 12 h apart); time to resumption of normal activity (i.e., a score of 0 on daily activities assessment scale)
5. Change in the symptom scores (influenza-like symptoms and respiratory symptoms) form baseline to end of treatment
Baseline, Day 8, Day 10
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "200" Final Enrollment numbers achieved (India)="200"
Phase of Trial
Phase 4
Date of First Enrollment (India)
16/12/2024
Date of Study Completion (India)
29/03/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
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
This is a Phase IV, prospective,
open-label, multi-centre phase randomized controlled trial of Viralex®
500mg and Viralex® 1000mg tablets in subjects with Influenza and
other acute respiratory viral Infections as per the marketing authorization in
India for assessment of safety and efficacy. The subjects will be
randomized to receive either Inosine
Pranobex 500 mg tablet or Inosine Pranobex 1000 mg tablets in a 1:1 ratio, in
doses and duration as defined in this study protocol.