| CTRI Number |
CTRI/2025/02/080826 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can cold wet cloth application on the eyes help reduce symptoms of dry eyes. |
|
Scientific Title of Study
|
Evaluate the efficacy of cold compress to eye on tear production and OSDI score in keratoconjunctivitis sicca - A Randomized control 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 N Sheerin Izzath |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block First floor, Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6369086249 |
| Fax |
|
| Email |
dr.sheerinkhan26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department - Naturopathy (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block First floor, Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department - Naturopathy (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block First floor, Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, 603001,Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Dr N Sheerin Izzath |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block First floor, Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001 |
| 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 N Sheerin Izzath |
International Institute of Yoga and Naturopathy Medical sciences |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Building :Faculty block First floor, Division :Branch I, Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU |
6369086249
dr.sheerinkhan26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H162||Keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold compress to eye. |
The Subjects in the group will be given yoga and naturopathic interventions with cold compress.The compress consists of a 9cm x 6cm x 1cm sterile linen cloth, soaked in sterile cold water(55°F-65°F) stored in a sterile mud pot. extra water in the cloth will be wrung out and compress applied to the skin of closed eyelids for 20 minutes, the compress will be renewed every 5min for 3 days a week for a period of 4 weeks. |
| Comparator Agent |
Yoga and Naturopathic intervention without cold compress |
Yoga and Naturopathic intervention without cold compress will be given for a period of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have Schirmer’s test one score less than ten millimetres in five minutes. Patients who can differentiate Hot and Cold. Patients who are willing to give consent. |
|
| ExclusionCriteria |
| Details |
Patients with defects of eyelid or eyelashes. Past history of surgical eye operations in the last three months. Eyeball or ocular appendage injuries. Active ocular infections. Taking systemic corticosteroids or immunosuppressant treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Schirmer’s test I score, Ocular Surface Disease Index |
Schirmer’s test I score and Ocular Surface Disease Index will be assessed at baseline and after 4 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual acuity test |
Visual acuity test will be assessed using the Snellens chart at baseline & after 4 weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="1"
Months="2"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sheerinkhan26@gmail.com].
- For how long will this data be available start date provided 17-02-2025 and end date provided 15-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Keratoconjunctivitis sicca, commonly known as dry eye syndrome, is a highly prevalent condition affecting 5-55% of the global population. It is often underdiagnosed and can significantly impact daily life activities such as reading, writing, and driving. Dry eye syndrome is characterized by loss of homeostasis of the tear film, leading to ocular symptoms, inflammation, and damage.
The condition can be classified into two groups: evaporative dry eye and aqueous deficiency dry eye. Intrinsic factors contributing to dry eye disease include increasing age, female gender, and certain autoimmune conditions. Extrinsic factors, such as digital screen use, contact lens wear, and environmental factors, also play a significant role. Symptoms of dry eye disease include ocular dryness, discomfort, pain, grittiness, foreign body sensation, visual abnormalities, and redness.
This study aims to evaluate the efficacy of cold compress treatment in patients with keratoconjunctivitis sicca. Cold compress is a hydrotherapy treatment method that improves blood circulation, reduces inflammation, and promotes relaxation. Although it has been used in various ocular conditions, there is a lack of evidence in dry eye disease. This study will assess the impact of cold compress treatment on tear production, OSDI score, and visual acuity in patients with dry eye syndrome. |