| CTRI Number |
CTRI/2016/04/006891 [Registered on: 28/04/2016] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
"Ayurvedic management of the vision disturbance due to computer by the use of triphaladi compound and shunthyadi eye drop" |
|
Scientific Title of Study
|
"A clinical study on triphaladi compound and shunthyadi eye drops in the management of computer vision syndrome(CVS)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi prakash gupta |
| Designation |
Research Scholar |
| Affiliation |
IPGT and RA |
| Address |
DEPT OF SHALAKYA TANTRA IPGT AND RA Gujarat Ayurved University JAMNAGAR
IPGT AND RA Gujarat Ayurved University JAMNAGAR 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9978825431 |
| Fax |
|
| Email |
shashiprakash.5887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Manjusha R |
| Designation |
Professor and HOD of Shalakya dept. |
| Affiliation |
IPGT and RA |
| Address |
DEPT OF SHALAKYA TANTRA IPGT AND RA Gujarat Ayurved University JAMNAGAR
IPGT AND RA Gujarat Ayurved University JAMNAGAR 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Manjusha R |
| Designation |
Professor and HOD of Shalakya dept. |
| Affiliation |
IPGT and RA |
| Address |
DEPT OF SHALAKYA TANTRA IPGT AND RA Gujarat Ayurved University JAMNAGAR
IPGT AND RA Gujarat Ayurved University JAMNAGAR 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar – 361008 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATION TEACHING AND RESEARCH IN AYURVEDA |
| Address |
INSTITUTE FOR POST GRADUATION TEACHING AND
RESEARCH IN AYURVEDA OPP. CITY B 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 |
| Dr Shashi prakash Gupta |
IPGT and RA |
Department of shalakya Opd No 4 Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar –
361008
Jamnagar
GUJARAT |
9978825431
shashiprakash.5887@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
computer users complaining of eye strain irritation etc ie computer vision syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Triphaladi compound orally 6gm b.d. and Shunthyadi eye drops 4times or more if required per day for 6weeks |
| Comparator Agent |
Group B |
CMC(car boxy Methyl Cellulose)eye drops 0.5% 4times or more if required per day for 6 weeks and counseling for changing the working style and standards. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Computer users complaining of eye strain, irritation, blurred vision, redness, burning eyes, excessive tears, double vision and headache. Patients having minimum three symptoms of CVS.
2. Continuous 3hr/day and more than that exposure to any type of video display terminals(VDT) like desktop, laptop and similar devices. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing for registration.
2. Patients suffering from systemic and metabolic disorders like poly arthritis, rheumatoid arthritis, auto immune diseases, etc.
3.Use of non-specific B-blockers for longer time by glaucoma patients.
4.Patients using contact lenses.
3. Case complicated with acute/chronic infections and or inflammations of lid, conjunctiva, cornea and sclera.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that the trial drugs will exert a significant action over CVS(Computer Vision Syndrome).
|
6weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant Relief in the sign and symptoms of CVS(Computer Vision Syndrome). |
6weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/05/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Computer vision syndrome (CVS) is such a disease, and associated mainly with improper & long standing use of computer. The American Optometric Association defines CVS as that "complex of eye and vision problems related to near work which are experienced during use of computer".
CVS is characterized by visual symptoms like eye strain, dry eyes, eye irritation, blurred vision, headache, watering of eyes, redness, double vision etc.
|