| CTRI Number |
CTRI/2024/10/075259 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Supplements on Eye Pressure Among Individual Performing Physical Exercise |
|
Scientific Title of Study
|
Role of Supplements on Intraocular Pressure Among Individual Performing Resistance Exercise |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanush Sadashiva Poojary |
| Designation |
2nd year Master of Optometry student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Optometry Manipal College of Health Professions
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8431643971 |
| Fax |
|
| Email |
dhanush.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Judith Shefali Jathanna |
| Designation |
Assistant professor - Senior scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Optometry Manipal College of Health Professions
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008754240 |
| Fax |
|
| Email |
Judith.jathanna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dhanush Sadashiva Poojary |
| Designation |
2nd year Master of Optometry student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Optometry Manipal College of Health Professions
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8431643971 |
| Fax |
|
| Email |
dhanush.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher
Education, Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Dhanush Sadashiva Poojary |
| Address |
Department of Optometry Manipal college of Health Professions
Manipal Academy of Higher Education Manipal Udupi district
Karnataka India 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Dhanush Sadashiva Poojary |
Optometry clinic |
Room no: 315,
Optometry Clinic,
CTC Block,
Kasturba Hospital,
Manipal,
576104
Udupi
KARNATAKA |
8431643971
dhanush.mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers who are doing resistance exercise
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL
|
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Supplement users
Normal healthy individuals using supplements like whey protein, mass gainer, creatine monohydrates greater than 3 months
Under gym training greater than 1 year
At least 3 days of training in a week
Non supplement users
With ocular abnormality
With any ocular surgery, On either ocular or systematic medication effecting intraocular pressure
Systemic or ocular condition effecting intraocular pressure |
|
| ExclusionCriteria |
| Details |
Supplement users
Normal healthy individuals without using any supplements
Under gym training greater than 1 year
At least 3 days of training in a week
Non supplement users
With ocular abnormality
With any ocular surgery, On either ocular or systematic medication effecting intraocular pressure
Systemic or ocular condition effecting intraocular pressure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraocular pressure in mmHg |
Baseline and immediate after exercise, 30 min and 1 hour post workout |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
22/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a prospective cross sectional study. This study will involve conducting resistance training which is 3 sets of high bar squat exercise 6 repetition with 75% maximal load among 58 individual with age group of 18-40 years. Study will be take place in iron addicts gym, Manipal and xpose gym, Hiriadka. Primary outcome of the study will be to assess intraocular pressure among individual performing resistance exercise on supplement and non supplement users.
|