| CTRI Number |
CTRI/2017/12/010861 [Registered on: 13/12/2017] Trial Registered Prospectively |
| Last Modified On: |
12/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management Of Dry Eye Due To Excessive Use Of Computer |
|
Scientific Title of Study
|
A Controlled Clinical Trial on Shunthyadi Aschyotana(Eye Drops) in the management of Dry Eye (Due to excessive use of Computer) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandan Sharma |
| Designation |
Research scholar |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
Shalakya Tantra Department IPGT AND RA Gujarat Ayurved University Jamnagar
Shalakya Tantra Department IPGT AND RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9569379953 |
| Fax |
|
| Email |
chandanattri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D B Vaghela |
| Designation |
Associate professor and incharge HOD Shalakya Tantra Department IPGT AND RA |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
Shalakya Tantra Department IPGT AND RA Gujarat Ayurved University Jamnagar GUJARAT 361008 INDIA
Shalakya Tantra Department IPGT AND RA Gujarat Ayurved University Jamnagar GUJARAT 361008 INDIA
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D B Vaghela |
| Designation |
AssociateProfessor and incharge HOD Shalakya Tantra Department IPGT AND RA |
| Affiliation |
IPGT AND RA GAU JAMNAGAR |
| Address |
Shalakya Tantra Department IPGT AND RA Gujarat Ayurved University Jamnagar GUJARAT 361008 INDIA
Shalakya Tantra Department IPGT AND RA Gujarat Ayurved University Jamnagar GUJARAT 361008 INDIA
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching And Research In Ayurveda Jamnagar Gujarat Ayurved University |
| Address |
Institute for Post Graduate Teaching And Research In Ayurveda Jamnagar Gujarat Ayurved University Opposite City B Division Police Station PN Marg Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chandan sharma |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
Department of Shalakya Tantra Opd No 4 Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008
Jamnagar
GUJARAT |
9569379953
chandanattri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 PGT/7/-A/Ethics/2017-2018/2097 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having sign and symptoms of dry eye due to excessive use of computer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A
|
Shunthyadi Aschyotana(eye drops) 1 drop 4 times per day in each eye for 4 weeks |
| Comparator Agent |
Group B |
CMC(carboxy Methyl Cellulose)eye drops 0.5% one drop four times per day in each eye for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Computer users complaining of feeling of dryness irritation foreign body sensation itching burning sensation ocular discomfort slow refocusing of eye
2 Patients in the age group 18 to 50 years irrespective of sex caste religion
3 Continuous 3hour per day and more than that exposure to any type of video display terminals like desktop laptop and similar devices
|
|
| ExclusionCriteria |
| Details |
1 Patients not willing for registration
2 Patient in the age group less than 18 years or more than 50 years
3 Dry Eye due to any local cause eg allergic conjunctivitis xerosis etc
4 Dry Eye due to systemic disease like Sjogrens Syndrome
5 Case complicated with acute/chronic infections and/or inflammations of lid conjunctiva cornea and sclera
|
|
|
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 |
| It is expected that the trial drug will exert a significant action over Dry Eye due to excessive use of computer |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant relief in the sign and symptoms of Dry Eye due to excessive use of computer |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
15/02/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dry Eye due to excessive use of computer is such a disease that associated mainly with improper and long standing use of computer. It is characterized by visual symptoms like dry eyes foreign body sensation, itching burning sensation ocular discomfort, slow refocusing etc.Though lubricating drops can reduce the effects of Dry Eye due to excess use of Computer but its preservatives are harmful to eye. So long term use is not possible and effects of artificial drops are temporary.This opens the door to other systems of medicine including Ayurveda to suggest experiments and contribute alternative modalities to check the suffering of computer users. Hence a clinical study is proposed to evaluate the efficacy of Shunthyadi eye drops topically in the management of Dry Eye Due to excessive use of Computer |