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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H539||Unspecified visual disturbance. Ayurveda Condition: SARVAGATAKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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
2Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (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.

 
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