| CTRI Number |
CTRI/2016/02/006586 [Registered on: 01/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
22/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cold compress] |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effectiveness of cold compress on relieving the symptoms of allergic conjunctivitis among children of age group 5 – 15 years, residing in Dadu Majra Colony,UT,Chandigarh, 2013-2015. |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of cold compress on relieving the symptoms of allergic conjunctivitis among children of age group 5 – 15 years, residing in Dadu Majra Colony, UT, Chandigarh, 2013-2015. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
payal kahol |
| Designation |
student |
| Affiliation |
PGIMER |
| Address |
room no. 21 working women hostel, PGI, sec 12, Chandigarh
National Institute of Nursing Education, PGIMER,sec 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7837713102 |
| Fax |
0172-2744401 |
| Email |
palukahol@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Kumari Saini |
| Designation |
Lecturer |
| Affiliation |
PGIMER |
| Address |
National Institute of Nursing Education, PGIMER, sec 12, Chandigarh
National Institute of Nursing Education, PGIMER,sec 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09888038248 |
| Fax |
0172-2744401 |
| Email |
sushmadr_saini@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
payal kahol |
| Designation |
student |
| Affiliation |
PGIMER |
| Address |
room no. 21 working women hostel, PGI, sec 12, Chandigarh
National Institute of Nursing Education, PGIMER,sec 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7837713102 |
| Fax |
0172-2744401 |
| Email |
palukahol@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self financed |
| Address |
room no 12, Working women hostel, PGIMER, Sec 12, Chandigarh |
| Type of Sponsor |
Other [] |
|
|
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 |
| Payal Kahol |
Home visits |
Dadu Majra Colony, Chandigarh
pin-160014
Chandigarh
CHANDIGARH |
07837713102
palukahol@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee(intramural) Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Allergic Conjunctivitis, (1) ICD-10 Condition: H102||Other acute conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cold compress |
Application of clean (washed and dried in the Sun) cotton cloth dipped in cold water; squeezed out and applied for 5 minutes to each eye simultaneously twice a day, for 5 days in the experimental group |
| Comparator Agent |
control group |
no intervention is given to the control group |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group 5-15 yrs ; presenting with any two of the following symptoms – itching, ropy discharge, frequent eye rubbing ; along with redness or watering of eyes for minimum of 1 weeks. |
|
| ExclusionCriteria |
| Details |
Children having any eye injury. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in the intensity of the symptoms of allergic conjunctivitis in the experimental group |
decrease in the intensity of the symptoms of allergic conjunctivitis to less than 3 on severity scale from 0 to 10 on 6th day (post interventional assessment) in the experimental group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in the intensity of the symptoms of allergic conjunctivitis in the experimental group |
daily decrease in the intensity of the symptoms of allergic conjunctivitis on scale from 0 to 10 assessed for 6 days in the experimental group |
|
|
Target Sample Size
|
Total Sample Size="217"
Sample Size from India="217"
Final Enrollment numbers achieved (Total)= "217"
Final Enrollment numbers achieved (India)="217" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2014 |
| Date of Study Completion (India) |
31/08/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/08/2014 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized control trial to asses the effectiveness of cold compress on relieving the symptoms of allergic conjunctivitis being conducted in community setting. Total 217 subjects of age group 5-15 years were selected and randomly allocated to experimental and control group. The primary outcome is the reduction in the severity of the symptoms of allergic conjunctivitis to below 3 on 1-10 scale |