| CTRI Number |
CTRI/2025/07/091181 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Child Resistant Packaging Testing Study |
| Study Design |
Other |
|
Public Title of Study
|
Child Resistant Packaging testing (Dropper) |
|
Scientific Title of Study
|
Design Factors for Evaluating Child Resistant Packaging (Dropper) testing for children safety and
senior friendly |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati |
| Designation |
Clinical Operations Lead |
| Affiliation |
Resyte Pharma Research Private Limited |
| Address |
Department of Clinical Operations, Ground floor,
Street-6, Vijayapuri colony, Tarnaka, Lallaguda, Secunderabad,
Hyderabad
TELANGANA
500017
India |
| Phone |
9760147377 |
| Fax |
|
| Email |
clinops@resyt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dundesh Maled |
| Designation |
Consultant General Physician |
| Affiliation |
Vagus Super Speciality Hospital Private Limited |
| Address |
Department of Pharmacology,
Ground Floor, Malleshwaram, 18th cross,
Bangalore
KARNATAKA
560055
India |
| Phone |
9980077844 |
| Fax |
|
| Email |
drmaleddundesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati |
| Designation |
Clinical Operations Lead |
| Affiliation |
Resyte Pharma Research Private Limited |
| Address |
Department Of Clinical Operations,Ground floor,Street-6, vijayapuri colony, Tarnaka, Lallaguda, Secunderabad,
Hyderabad
TELANGANA
500017
India |
| Phone |
9760147377 |
| Fax |
|
| Email |
clinops@resyt.com |
|
|
Source of Monetary or Material Support
|
| East Pharma Technologies
Level 21, Galaxy, Opp. IKEA, Hyderabad Knowledge city,
Ranga Reddy (Dt), Hyderabad, Telangana 500032 |
|
|
Primary Sponsor
|
| Name |
East Pharma Technologies |
| Address |
Level 21, Galaxy, Opp. IKEA, Hyderabad Knowledge city,
Ranga Reddy (Dt), Hyderabad, Telangana 500032 |
| Type of Sponsor |
Other [Packaging and containers manufacturing] |
|
|
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 Dundesh Maled |
Vagus Super Speciality hospital private limited |
Department of pharmacology,Ground floor,6-8, Malleshwaram, 18th Cross
Bangalore
KARNATAKA |
9980077844
drmaleddundesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
As this is a child-resistant packaging study, no specific health conditions of the trial participants will be studied. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
42.00 Month(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Children aged between 42 to 51 months, Senior subjects aged 50 -70 years at the time of testing
2) Have IEC/IRB approved consent form signed by subject, parent or guardi3)
3) Haver permission to be videotaped Provide verbal assent (or assent through body language-
head nod, etc). |
|
| ExclusionCriteria |
| Details |
1) No history of food allergies of any kind
2) No known issues with plastic or allergy
3) Have no physical or mental impairments that impact their ability to open packages.
4) Subjects with overt or obvious disabilities.
5) Adult subjects with a permanent or temporary illness, injury, or disability that would interfere with his/her effective participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Child Test:
1) Proportion of successful openings within a given time (First five minutes OR Second five
minutes).
2) Time to successful opening (First five minutes OR Second five minutes) (Openings will be
recorded as child was successful yes/no).
Senior Test:
1)Proportion of successful openings within a given time.
2)Time to successful opening.
3)Number of successful attempts
4)Number of failed attempts
5)Average time to open |
One day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Protocol Title: Design factors for evaluating child resistant packaging testing for children safety and senior friendly. Study Design: A single center observational study. Duration of study: The minimum duration for the study will be one month. Number of subjects : 100 subjects children aged between 42 to 51 months, senior subjects aged 50 to 70 years will be recruited in the study in 2 groups (50 children i n child test group ( Group-A), 50 senior subjects in senior test Group (Group-B)). |