| CTRI Number |
CTRI/2022/07/044273 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [THERAPEUTIC] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on Digital eye strain and its management with ksheera kashaya prepared with Yashti and Ushira pouring in the closed eye and Nasal instillation of Jeevanthyadi thailam. |
|
Scientific Title of Study
|
A clinical study on Digital eye strain and its management with Yashti Ushira ksheera seka and Jeevanthyadi thaila Prathimarsha nasyam. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusree R |
| Designation |
PG Scholar |
| Affiliation |
Govt. Ayurveda College, Thiruvananthapuram |
| Address |
Department of Shalakyathantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
8547978337 |
| Fax |
|
| Email |
anusree0893@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kusumam Joseph |
| Designation |
Professor |
| Affiliation |
Govt. Ayurveda College, Thiruvananthapuram |
| Address |
Department of Shalakyatantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9446187163 |
| Fax |
|
| Email |
kusumamjoseph123@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kusumam Joseph |
| Designation |
Professor |
| Affiliation |
Govt. Ayurveda College, Thiruvananthapuram |
| Address |
Department of Shalakyatantra
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9446187163 |
| Fax |
|
| Email |
kusumamjoseph123@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
|
|
Primary Sponsor
|
| Name |
Govt Ayurveda College Thiruvananthapuram |
| Address |
GOVT. AYURVEDA MEDICAL COLLEGE
PULIMOODU JUNCTION
THIRUVANANTHAPURAM
695001 |
| Type of Sponsor |
Government 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 |
| Dr Anusree R |
Government Ayurveda College Thiruvananthapuram |
Department of Shalakyatantra
OP No 5 Thiruvananthapuram KERALA |
8547978337
anusree0893@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE (IEC) GOVT AYURVEDA COLLEGE, THIRUVANANTHAPURAM, KERALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H539||Unspecified visual disturbance. Ayurveda Condition: SARVAGATAKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sekaH, सेकः | (Procedure Reference: SUSRUTHA SAMHITHA , Procedure details: POURING KSHEERA KASHAYA PREPARED WITH YASHTI AND USHIRA IN THE CLOSED EYE,TWICE DAILY) (1) Medicine Name: YASHTI AND USHIRA, Reference: Gyanendra Pandey. Dravyaguna Vinjaneeya,Vol 2 ,Chaukhambha Orientalia Varanasi; 2004.and Gyanendra Pandey. Dravyaguna Vinjaneeya, Vol-3, Chaukhambha Orientalia Varanasi;2004, Route: Ocular, Dosage Form: Ksheerpaka, Dose: 300(ml), Frequency: bd, Duration: 2 Weeks | | 2 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Dr.T.Sreekumar. Ashtangahridaya. 3rdedition, Vol 2, Procedure details: NASAL INSTILLATION OF JEEVANTHYADI THAILA TWICE DAILY) (1) Medicine Name: JEEVANTHYADI THAILA, Reference: Prof.Dr. K.R. Srikantamurthy. Ashtangahridaya- Utharasthana. Krishnadas Academy Varanasi; 2012,p 122, Route: Nasal, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Duration: 2 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of age group 15-40 irrespective of sex
2. Individuals who were using digital devices for more than 1 year
3. Minimum 4hrs/day exposure to any type of video display terminals such as desktop, laptop and smartphones
4. Having at least 5 symptoms of digital eye strain such as headache, watering of eyes, grittiness, blurred vision, redness, eye pain, feeling dryness of eyes, burning sensation of eyes, itching of eyes, double vision, foreign body sensation, intolerance to light and difficulty to focus for near vision. participants must have redness, eye pain, grittiness, burning sensation as their main symptoms.
5. Best corrected visual acuity better than or equal to 6/12 in worse eye.
6. Individual who fit for prathimarsha nasya with jeevanthyaditaila.
|
|
| ExclusionCriteria |
| Details |
1.Contact lens users
2.Ocular allergic conditions
3.Corneal ulcer
4.Ocular injuries
5.known cases of glaucoma and diabetes mellitus
6.Person use eye drops for the last 6 months
7.Subjects who have undergone any surgeries in eye
8.Lid motility disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Outcome variables
Subjective parameters
Redness
Eye pain
Grittiness
Burning sensation of eyes
Objective parameters
Schirmer-1 test, Tear film break up time
|
0,15 and 30th days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HEAD ACHE
ITCHING OF EYES
INTOLERANCE TO LIGHT |
0,15,30th days |
|
|
Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Digital eye strain (DES) or computer vision syndrome,
as defined by the American optometric association, encompasses various visual
and ocular symptoms arising due to the prolonged use of digital electronic
devices. The most common symptoms associated with DES are Eye strain, Headache,
Blurred vision, Dry eye, Redness, Intolerance to light, Grittiness, Burning
sensation and pain in the neck and shoulders. The use of gadgets has grown in
the last decade due to the massive growth in the internet and digital device
technology. The corona virus pandemic has necessitated drastic lifestyle changes
which increases exposure to digital devices. In modern science, only ocular
surface lubricant, use of computer glasses & counselling for judicious
computer use is advised1. According to Ayurveda on analysing symptoms
of DES, it is evident that vatha pitha dosha kopa and kapha kshaya play a major
role in the genesis of DES. So for the management of DES drugs which have
seetha, snigda, brimhana, and vathapithahara properties is needed. Yashti,ushira
and drugs included in jeevanthyadithaila have these properties. There for, the
study is planned to assess the effect of Ksheeraseka with yashti and ushira, Prathimarsanasya
with jeevanthyadi thailam for reducing signs and symptoms of digital eye
strain. The study design is pre and post interventional study with a sample
size of 26 participants in the age group of 15-40 years with digital eye strain from
OPD of Shalakyatantra, Govt. Ayurveda College Thiruvananthapuram. The effect of
the treatment will be assessed on the improvement in the subjective symptoms
namely redness, eye pain, grittiness, burning sensation and the objective
parameters which include schirmer 1 test2 and tear film break up
time3. Jeevanthyadithaila prepared in mridupaka according to
snehakalpanavidhi mentioned in sarngadarasamhitha4 will be taken for
prathimarsha nasya5 approximately 1 ml instilled in each nostril. Ksheera
Kashaya will be prepared by taking 1part yashti ushira choornam, 64part water
and 16part milk boiled together, after cooling about 300 ml yashti ushira
ksheera Kashaya will be used for seka6 in each eye. These two
procedures should be done twice daily for 14 days. The patient will be assessed
on 0th,15th and 30th day of treatment. Result
will be statistically analysed after the study. |