Clinical Study to Evaluate the Efficacy and Safety of GRIPOUT tablet in the Treatment of common cold and flu syndrome

Phase 3

Completed

• Conditions: Health Condition 1: J398- Other specified diseases of upperrespiratory tract

• Registration Number: CTRI/2020/05/025373
• Lead Sponsor: EURO LIFE CARE PVT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified