Health Condition 1: J398- Other specified diseases of upperrespiratory tract
Conditions
Interventions
Intervention1: GRIPOUT Tablet: Tablets for oral route Three times a day for three days
Intervention2: GRIPOUT Tablet of Marksans Pharma Ltd.: Tablets for oral route Three times a day for three days
Co
Sponsors
EURO LIFE CARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet the following criteria will be considered eligible to participate in the study 1.Male or Female having the age of 18 to 55 years 2.Presented symptoms of recent onset, for more than 6 hours and less than 72 hours characterizing one of the following conditions The common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points The flu syndrome, which consists of fever of at least 100.58°F and headache of moderate or severe intensity or myalgia or arthralgia moderate or severe using a scale of severity of symptoms of 4 points 3.Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Patients who are not willing to give written informed consent. 2.Any known hypersensitivity to the study products. 3.Pregnant and lactating women. 4.Any history of seasonal or perennial allergic rhinitis. 5.Patients who have taken treatment for the presenting symptom within 7 days of screening. 6.Use of monoamine oxidase inhibitors or barbiturates 7.Patients who received influenza vaccine within 7 days of screening. 8.Patients who in the opinion of attending physician may require antibiotic treatment. 9.Any lab findings or clinical findings that in the opinion of treating physician may appear as risk to the patient. 10.Participation in any clinical trials prior to 30days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Assess the symptomatic relief of common cold and flu syndrome at the early basis to check the efficacy of test product 1, test product 2 and placebo.Timepoint: Baseline to end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Significant changes in VAS scores from baseline to EOT as hourly basis 2 Time to complete recovery from flu and cold syndrome 3 Tolerance of IP 4 Assessment of safety of Investigational product: Adverse event Physical examination Timepoint: Baseline to end of treatment | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd
Outcome results
None listed