| CTRI Number |
CTRI/2024/11/076509 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate the Safety and Effectiveness of the
GOODAIR 2.0 Non-Electric Car Air Purifier in mitigating motion sickness in individuals engaged in daily car travel |
|
Scientific Title of Study
|
A randomized, double blinded study to evaluate the safety and effectiveness of the
GOODAIR 2.0 Non-Electric Car Air Purifier in comparison with placebo Non-Electric Car
Air Purifier in mitigating motion sickness in individuals engaged in daily car travel |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shyam Mukundan |
| Designation |
Consultant Physician |
| Affiliation |
Lakshmi Nursing Home |
| Address |
Lakshmi Nursing Home
Department of General Medicine
Room No 8
Palace Road Aluva
Ernakulam
KERALA
683101
India |
| Phone |
04842625369 |
| Fax |
|
| Email |
drshyammukundan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Mukundan |
| Designation |
Consultant Physician |
| Affiliation |
Lakshmi Nursing Home |
| Address |
Lakshmi Nursing Home
Department of General Medicine
Room No 8
Palace Road Aluva
Ernakulam
KERALA
683101
India |
| Phone |
04842625369 |
| Fax |
|
| Email |
drshyammukundan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Mukundan |
| Designation |
Consultant Physician |
| Affiliation |
Lakshmi Nursing Home |
| Address |
Lakshmi Nursing Home
Department of General Medicine
Room No 8
Palace Road Aluva
Ernakulam
KERALA
683101
India |
| Phone |
04842625369 |
| Fax |
|
| Email |
drshyammukundan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Team Green Innovations Pvt Ltd
Corporation Zonal Office Door No 38 2846 A2 South P O Edapally Kochi Kerala 682024 |
|
|
Primary Sponsor
|
| Name |
Team Green Innovations Private Limited |
| Address |
Corporation Zonal Office Near Door No 38 2846 A2
South P O Edappally Kochi Kerala 682024 |
| Type of Sponsor |
Other [Private] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shyam Mukundan |
Lakshmi Nursing Home |
Department of General Medicine Room No 8 Palace Road Aluva 683101
Ernakulam
KERALA |
04842625369
drshyammukundan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lakshmi Nursing Home |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Motion Sickness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with significant history of motion sickness while traveling in car |
|
| ExclusionCriteria |
| Details |
Subjects suffering from head injuries, infections and other diseases of the ear and neurological systems |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of the GOODAIR 2.0 non-electric car air purifier in minimizing
motion sickness and its associated symptoms in individuals who travel by car on a daily basis |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Analyse the safety of GOODAIR 2.0 Non-electric car air purifier |
1 Month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/11/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|