| CTRI Number |
CTRI/2024/11/076119 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Child Resistant Packaging testing |
| Study Design |
Other |
|
Public Title of Study
|
child resistant packaging study |
|
Scientific Title of Study
|
Design Factors for Evaluating Child Resistant Packaging 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 |
12-5-35/A/6, StreetNo-6,Vijayapuri colony, Tarnaka, Lallaguda, Secunderabad,
Telangana
Hyderabad
TELANGANA
500017
India |
| Phone |
9760147377 |
| Fax |
|
| Email |
clinops@resyt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Kumar Macherla |
| Designation |
General physician |
| Affiliation |
St. Theresas Hopital |
| Address |
Department of pediatrics, room No-36, 1st floor, sanathnagar hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
8008220098 |
| Fax |
|
| Email |
Kiran.macherla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Swati |
| Designation |
Clinical operations lead |
| Affiliation |
RESYTE PHARMA RESEARCH PRIVATE LIMITED |
| Address |
12-5-35/A/6, StreetNo-6,Vijayapuri colony, Tarnaka, Lallaguda, Secunderabad,
Telangana
Hyderabad
TELANGANA
500017
India |
| Phone |
9760147377 |
| Fax |
|
| Email |
clinops@resyt.com |
|
|
Source of Monetary or Material Support
|
| Energon Labs Private Limited,
Plot No 10-B, H No 5-36/1/10B TSIIC,
Kukatpally Village, Balanagar Mandal,
Hyderabad, Telangana 500072, India (IND) |
|
|
Primary Sponsor
|
| Name |
Energon Labs Private Limited |
| Address |
Plot No 10-B, H No 5-36/1/10B TSIIC,
Kukatpally Village, Balanagar Mandal,
Hyderabad, Telangana 500072, India (IND) |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Kiran Kumar Macherla |
St. Theresas Hospital |
Department of pediatrics, room No-36, 1st floor, sanathnagar hyderabad
Hyderabad
TELANGANA |
8008220098
Kiran.macherla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, St. Theresas hospital |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
42.00 Month(s) |
| Age To |
51.00 Month(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 guardian.
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
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
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 friendly test
1) Proportion of successful openings within a given treatment.
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 |
| None |
NA |
|
|
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)
|
11/11/2024 |
| 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 the study: The minimum duration of the study will be 1 month. Number of subjects: 100 subjects Children aged between 42 to 51 months, Senior subjects aged 50 -70 years will be
recruited in the study in 2 groups (50 children in child test group (group-A), 50 senior subjects
in senior test group (group-B)).
|