| CTRI Number |
CTRI/2018/08/015437 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
20/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
compare the effect of eye exercises and eye exercises with goghrit(ghee) instilation in the eyes in the patients of digital eye strain |
|
Scientific Title of Study
|
A comparative clinical study of eye exercise with and without Goghrut Aschotan in the management of digital eye strain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AMIT DHANANJAY WANKHEDE |
| Designation |
MS Shalakyatantra Final Year |
| Affiliation |
PDEAs C.A.R.C. NIGADI |
| Address |
PDEAs Ayurved Rugnalaya and Sterling multi speciality hospital sector 27 Nigdi Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
8007833777 |
| Fax |
|
| Email |
patilamit157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna P Bhoite |
| Designation |
MS Shalakya |
| Affiliation |
PDEAs C.A.R.C. Nigdi |
| Address |
PDEAs C.A.R.C Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9423585654 |
| Fax |
|
| Email |
aparnabhoite@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AMIT DHANANJAY WANKHEDE |
| Designation |
MS Shalakyatantra Final Year |
| Affiliation |
PDEAs C.A.R.C. Nigdi |
| Address |
PDEAs Ayurved Rugnalaya and Sterling multi speciality hospital sector 27 Nigdi Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
8007833777 |
| Fax |
|
| Email |
patilamit157@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYURVED RUGNALAY AND STERLING MULTI SPECIALITY HOSPITAL Shalakya department (Netra)Ground floor Nigdi Pradhikaran Sector 27,Pune 44 |
|
|
Primary Sponsor
|
| Name |
Ayurved college and research center |
| Address |
Nigadi Pune |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrAmit Wankhede |
ayurved rugnalay and multispeciality hospital |
Sector number 27 Nigadi Pradhikaran Pune 44 Ground floor Shalakya department Division-(Netra)
Pune
MAHARASHTRA |
8007833777
patilamit157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eye exercises |
eye exercises-Palming, Flexing, Zooming, Palming, Massaging, Image figure 8,Swinging,Blinking,Palming.
Duration of treatment is 15days with follow up at 1st, 7th, 15th day |
| Intervention |
Eye exercises with Goghrut Aschotan |
eye exercises-Palming, Flexing, Zooming, Palming, Massaging, Image figure 8,Swinging,Blinking,Palming.
Goghrut Aschotan-5 drops of goghrut instilled in the patients eyes two times a day(morning and evening) Duration of treatment is 15days with follow up at 1st, 7th, 15th day.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Dryness of eye
Transient blurring of vision
Burning sensation in eyes
Foreign body sensation
Eye strain
Headache
Patient with written consent |
|
| ExclusionCriteria |
| Details |
Patient having infective eye diseases
One eyed patients
Patient having active systemic diseases and autoimmune diseases
Chemical burn of eyes, injuries to eyes, corneal lesions and keratitis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Schirmer test is
Normal on 15mm wetting
Mild on 10mm- 15mm wetting
Moderate on 5mm-10mm wetting
Severe on 5mm wetting
|
tear film break up time(TFBUT)
Normal on 15-30 seconds
Mild 10-15 seconds
Moderate on 10 seconds
Severe on 5 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gradation will be done on the basis of following criteria-Absent, Mild, Moderate, Severe in the following signs and symptoms
Netra shushkata(dryness of eyes)
Gharshan(Foreign body sensation)
Awildarshan(Transient blurring of vision)
Netratan(Eye strain)
Netra daah(Burning sensation of eyes)
Shiroshool(headache) |
nill |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/09/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Since eyes are the most important sensory organ of the human body but due to increasing urbanization and changing lifestyle they are being exploited. Digital eye strain is a common eye problem seen nowadays from a very young age due to excessive use of digital gadgets, so to know different ways of preventing and curing this disease this study is being carried out. |