| CTRI Number |
CTRI/2023/11/060354 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
23/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of mud pack to eyes on digital eye strain |
|
Scientific Title of Study
|
Effect of mud pack to eyes on digital eye strain - a randomized controlled trial |
| 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 Meghana M |
| Designation |
PG Scholar |
| Affiliation |
Alvas college of Naturopathy and Yogic sciences |
| Address |
Room number 9, Department of clinical Naturopathy, Alvas college of Naturopathy and Yogic sciences, Moodbidri, Mangalore taluk
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9743489738 |
| Fax |
|
| Email |
meghana21997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineetha A N |
| Designation |
Associate professor |
| Affiliation |
Alvas college of Naturopathy and Yogic sciences |
| Address |
Room number 9, Department of clinical Naturopathy, Alvas college of Naturopathy and Yogic sciences, moodbidri, mangalore taluk
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8861064135 |
| Fax |
|
| Email |
vineethabnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghana M |
| Designation |
PG Scholar |
| Affiliation |
Alvas college of Naturopathy and Yogic sciences |
| Address |
Room number 9, Department of clinical Naturopathy, Alvas college of Naturopathy and Yogic sciences, moodbidri, mangalore taluk
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9743489738 |
| Fax |
|
| Email |
meghana21997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas college of Naturopathy and Yogic sciences, tenkamijar, Shobavana campus, Moodbidri, Mangalore taluk, karnataka, 574225 |
|
|
Primary Sponsor
|
| Name |
Dr Meghana M |
| Address |
Department of clinical naturopathy, Alvas college of Naturopathy and Yogic sciences, Tenkamijar, Shobavana campus, Moodbidri, Mangalore taluk, karnatka, 574225 |
| 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 Megahna M |
Alvas institute of Engineering and technology |
Department of information and technology, Mijar, Moodbidri, mangalore taluk, 574225
Dakshina Kannada
KARNATAKA |
09743489738
meghana21997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee for human studies of Alvas college of Naturopathy and Yogic sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Digital eye strain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold compress |
A cloth will be placed in cold water of 12-20 ËšC and wrung out enough so it does not drip. Then it will be applied over the eyes for 20 minutes. Frequency will be renewed, every 1-5 minutes for temperature |
| Intervention |
Mud pack |
A half inch thick layer of mud soaked in water will be
spread and made as a pack typically 9 in X 6 in which covers the eyes completely. It will be kept on the eyes for a duration of 20 minutes. After the treatment, the pack will be removed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects exposed to digital devices for minimum of 5 hours or more daily for last
3 months.
2) Subjects having history and diagnosed of digital eye strain.
3) Subjects willing to participate in the study by giving a signed informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with a history of ocular disease in either eye.
2) Subjects under systemic medications such as antihistamines, anti-cholinergic,
thyroid hormones, anti-thyroid drugs and Ginko biloba extracts will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Computer Vision Syndrome Questionnaire (CVS-Q)
2) Visual Fatigue Scale Questionnaire
3) Blink rate measurement |
Baseline and after 30 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/12/2023 |
| 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
|
Digital eye strain (DES) is a condition characterized by
visual disturbance and/or ocular discomfort related to the
use of digital devices and resulting from a range of stresses
on the ocular system, including glare, defocus,
accommodation dysfunction, fixation disparity, dryness,
fatigue and discomfort. Numerous studies suggest that ergonomic strategies may
be important for the management of digital eye strain.
Considered to be acceptable ergonomic practices are the
use of appropriate lighting, careful placement of the digital
device, changing the image properties (resolution, text
size, contrast, brightness), and taking pauses in
between. The concept "complementary and alternative medicine"
(CAM) encompasses a variety of medical and health care
methods, systems, and services that are not viewed as
being a part of traditional medical treatment. Treatments like mud therapy, hydrotherapy and
acupuncture can be used to alleviate the symptoms of
digital eye strain. Typically, mud packs are applied locally.
A mudpack’s design and use are same for all applications,
though the thickness and size vary depending on the
purpose. Due to massive growth in
digital device usage in recent times, many millions of
individuals of all ages are being affected by digital eye
strain. Despite the clinical efficacy of mud pack, there is a
lack of proper research evidence in this regard. Hence, the
present study will be conducted to evaluate the efficacy of
mud pack to eyes among individuals with digital eye
strain. |