Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Viralex® (Inosine Pranobex): Viralex® (Inosine Pranobex 500 mg tablets),
Route: Oral.
Frequency: Three times daily for 7 days.
Intervention2: Viralex® (Inosine Pranobex): Viralex® (Inos
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects reporting treatment-emergent AEs (TEAEs) at EOS.Timepoint: Day 10, End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 treatmentTimepoint: Baseline, Day 8, Day 10 | — |
Countries
India
Contacts
Public ContactDr Balaji More
Themis Medicare Limited
Outcome results
None listed