| CTRI Number |
CTRI/2011/07/001914 [Registered on: 26/07/2011] Trial Registered Prospectively |
| Last Modified On: |
09/08/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a device (water based gel) in healthy volunteers for prevention of cold and flu. |
|
Scientific Title of Study
|
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.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TTK-MAPB-MN01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sumbul Siddiqui |
| Designation |
Medical Monitor |
| Affiliation |
Max Neeman International |
| Address |
Max Neeman International,
Max House, 1st Floor,
1, Dr Jha Marg,
Okhla - III
New Delhi - 110 020.
South
DELHI
110020
India |
| Phone |
91-8130666357 |
| Fax |
91-11-41001945 |
| Email |
ssiddiqui@neemanasia.com |
|
Details of Contact Person
Public Query
|
| Name |
Shariq Anwar |
| Designation |
Director Operations |
| Affiliation |
Max Neeman International |
| Address |
Max Neeman International,
Max House,1 Dr. Jha Marg, Okhla Phase III,
New Delhi - 110 020,
India.
South
DELHI
110020
India |
| Phone |
91-11-40772100 |
| Fax |
91-11-40548168 |
| Email |
sanwar@neemanasia.com |
|
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Source of Monetary or Material Support
|
| Trutek Corp.,
281 East Main Street,
Somerville, NJ 08876, USA
|
|
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Primary Sponsor
|
| Name |
Trutek Corp |
| Address |
281 East Main Street,
Somerville, NJ 08876, USA.
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| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Max Neeman International |
Max House,
1,Dr. Jha Marg, Okhla III
New Delhi, 110020,
India |
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishnu Bhutia |
Agrasen Hospital |
Consultant Physician
Agrasen Hospital
76, Devi Nagar,New Sanganer Road, Jaipur-302019, Rajasthan, India
Jaipur
RAJASTHAN |
91-141-2292000
vishnubhutia@yahoo.co.in |
| Dr Arpit Jain |
Artemis Health Institute |
Consultant, Internal Medicine,
Artemis Health Institute,
Sector- 51, Gurgaon-122001, Haryana.
Gurgaon
HARYANA |
91-0124-6767999
91-0124-6767701
arpit@artemishealthsciences.com |
| Dr Sandeep Jain |
Tagore Hospital & Research Institute |
Consultant Physician
Tagore Hospital & Research Institute
Tagore Lane, Sector-7, Shiprapath, Madhyam Marg, Mansarover, Jaipur-302020, Rajasthan, India
Jaipur
RAJASTHAN |
91-9414069583
91-141-2785555
drsandeeprjain@yahoo.co.in |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Review Board, Sector-51, Gurgaon, Haryana-122001, India |
Approved |
| Sanjeevani Ethics Committee, Show Room No. B-2, Near Laxmi Mandir Cinema, Tonk Road, Jaipur-302015, Rajasthan, India |
Approved |
| Sanjeevani Ethics Committee, Show Room No. B-2, Near Laxmi Mandir Cinema, Tonk Road, Jaipur-302015, Rajasthan, India |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To determine the safety and efficacy of MAPB prevention of cold and flu |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi Acting Nasal Particle Blocker |
Mechanism Of Action: Multi Acting Nasal Particle Blocker is a clear, water-based, positively charged gel that works like an electrostatic filter by snagging negatively charged airborne particles that come very close to the applied gel before they enter the nasal passages.
Route of Administration: Topical.
Dosage: Two drops of gel, to be applied in the form of a thin film in and around the nostrils, on the septum, inside the nares and under the nose/above the upper lip. To be used 4-6 times a day.
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| Comparator Agent |
No treatment control group |
subjects who are in no treatment Group will be assessed for primary & secondary outcomes
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female subjects, 18 to70 years (inclusive) of age.
2. Willing to sign the written informed consent form.
3. Willingness to comply with the test procedure.
|
|
| ExclusionCriteria |
| Details |
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.
1. Subjects who have planned travel outside study area for a substantial portion of the study period.
2. Subjects who have gotten the flu shot within the last twelve months will not be allowed to participate.
3. 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.
5. Subjects who have received any investigational product within 30 days of enrollment.
6. Subjects who have history of allergic rhinitis expected to occur during the study period.
7. Subjects who have used any antiviral influenza medications within 2 weeks of screening or during the study period.
8. Subjects who have documented infection within two weeks prior to screening.
9. Subjects who have any chronic medical condition treated within 3 months prior to screening.
10. Subjects who have any systemic immunologic or immunosuppressive diseases.
11. Subjects who are scheduled for surgery during the study period.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| The percentage of subjects that are cold and/or flu free in the treatment arm |
At the end of study(Day 57) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of treatment related adverse events.
The percentage of subjects that are cold and/or flu free in the treatment arm
|
During the study at day 14, 28 and 42. |
|
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Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
28/07/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |