A clinical trial to study the effect of a device (water based gel) in healthy volunteers for prevention of cold and flu.

Phase 3

Completed

• Conditions: To determine the safety and efficacy of MAPB prevention of cold and flu

• Registration Number: CTRI/2011/07/001914
• Lead Sponsor: Trutek Corp

Brief Summary

A Randomized, Prospective, Open label, Parallel group, Comparative, Multi-Center Study to Determine the Safety and Efficacy of Truteks device Multi Acting Nasal Particle Blocker (MAPB) as a Preventive Treatment for Cold and Flu.

 ***Study Objectives:***

 The primary objective of the study is:

 1.To evaluate the efficacy of MAPB Nasal Application Gel in the prevention of the common cold and/or flu.

 The secondary objective of the study is:

 1.To evaluate the safety of MAPB Nasal Application Gel in the prevention of the common cold and/or flu.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-28
• Last Update Posted: 2012-09-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Male and Female subjects, 18 to70 years (inclusive) of age.
• Willing to sign the written informed consent form.
• Willingness to comply with the test procedure.

Exclusion Criteria

• Exclusion Criteria: Subjects who are more at risk for cold and/or flu or cold and/or flu complications than the general population such as serious respiratory problems, immune system disorders, and serious heart problems or individuals with other serious health problems may be excluded from the study if, at the discretion of the Principal Investigator, their participation would constitute a threat to their health.
• Subjects who report any two or more of the cold and/or flu symptoms in the past seven days with at least one significantly worsening in the past 1 to 4 days may be construed to have acquired cold and/or flu and excluded from the study.
• Subjects who have planned travel outside study area for a substantial portion of the study period.
• Subjects who have gotten the flu shot within the last twelve months will not be allowed to participate.
• Pregnant or nursing subjects.
• (There are, however, no risks for pregnant women and fetus by use, as directed, of the test article.) 4.
• Subjects who have had a life-threatening health emergency within the last six months will not be allowed to participate.
• Subjects who have received any investigational product within 30 days of enrollment.
• Subjects who have history of allergic rhinitis expected to occur during the study period.
• Subjects who have used any antiviral influenza medications within 2 weeks of screening or during the study period.
• Subjects who have documented infection within two weeks prior to screening.
• Subjects who have any chronic medical condition treated within 3 months prior to screening.
• Subjects who have any systemic immunologic or immunosuppressive diseases.
• Subjects who are scheduled for surgery during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of subjects that are cold and/or flu free in the treatment arm	At the end of study(Day 57)

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment related adverse events.	The percentage of subjects that are cold and/or flu free in the treatment arm

Trial Locations

Locations (3)

Agrasen Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Artemis Health Institute; 🇮🇳 Gurgaon, HARYANA, India

Tagore Hospital & Research Institute; 🇮🇳 Jaipur, RAJASTHAN, India

Agrasen Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Vishnu Bhutia

Principal investigator

vishnubhutia@yahoo.co.in