| CTRI Number |
CTRI/2023/07/054639 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on the effect of Ksheera Sandava seka on Eye Fatigue |
|
Scientific Title of Study
|
A pre and post clinical study on the effect of ksheera
saindava seka on eye fatigue A pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1292-3861 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnapriya suresh |
| Designation |
student |
| Affiliation |
Amrita School of Ayurveda |
| Address |
ROOM NO 407
Department ACARA
Amrita School of Ayurveda
Clappana PO Kollam Kerala 690525
ROOM NO 407
Department ACARA
Amrita School of Ayurveda
Clappana PO Kollam Kerala 690525
Kollam
KERALA
690525
India |
| Phone |
7025706494 |
| Fax |
|
| Email |
Krishnapriyasuresh790@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr preeti Mohan |
| Designation |
Associate professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda, Amritapuri, Kollam, Kerala,
Kollam
KERALA
690525
India |
| Phone |
919447320363 |
| Fax |
|
| Email |
drpreeti94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr preeti Mohan |
| Designation |
Associate professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda, Amritapuri, Kollam, Kerala,
KERALA
690525
India |
| Phone |
919447320363 |
| Fax |
|
| Email |
drpreeti94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashtanga Hridaya and Sushruta Samhita Sarvakshigataroga. |
|
|
Primary Sponsor
|
| Name |
Amrita School Ayurveda |
| Address |
Amrita School of Ayurveda, Amritapuri, Kollam, Kerala, |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Krishnapriya |
Amrita Ayurveda Hospital |
Amrita School of Ayurveda Clappana PO Vallickavu Kollam Kerala
Kollam
KERALA |
7025706494
krishnapriyasuresh790@gmail.com |
| Krishnapriya Suresh |
Amrita Ayurveda Hospital |
Room no 407 ACARA Office Amrita School of Ayurveda Clappana PO Kollam Kerala 690525
Kollam
KERALA |
7025706494
Krishnapriyasuresh790@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Amrita school of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
| Patients |
(1) ICD-10 Condition:H525||Disorders of accommodation. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, (2) ICD-10 Condition:H525||Disorders of accommodation. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | snehanasekaH aेहनसेक | (Procedure Reference: Sharangadhara, Procedure details: Preparation of Ksheerasaindavaseka:Two glasses of milk areadded with two glasses of normal water and boiled for 5-10 minutes.A pinch of rock salt is added when the milk comes to a boil. It ismade of lukewarm and used for pouring over closed eyes using Seka DharaYantra while the subject lies supine. The instrument is held approximately 4angula(8cm) from the eyes and done for 10-15 minutes.This procedure will be done for five days.)
(1) Medicine Name: Ksheera saindava, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 400(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
The individual with the best-corrected visual acuity is better than or equal to 20/20 (6/6)
Those who are symptomatic based on a validated eye fatigue questionnaire
|
|
| ExclusionCriteria |
| Details |
1)Individuals with a systemic or ocular pathology, ocular surgery.
2) High ametropia (≥ ± 6.00 D)
3) Strabismic anomaly
4) Undergoing any kind of vision therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Ksheera Saindhava Seka Kriyakalpa on Eye fatigue |
five days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of Seka in Eye fatigue using the eye fatigue scale.
• To evaluate the effectiveness of Seka in improving dry eye using Schirmers test
|
Five Days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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="0"
Months="2"
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)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Krishnapriyasuresh790@gmail.com].
- For how long will this data be available start date provided 01-08-2023 and end date provided 01-08-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
People who spend a lot of time staring at
screens on TVs, computers, smartphones, and other electronic devices sometimes experience
eye fatigue because doing so slows down blinking, which in turn affects tear
production. Flashing screens at the same moment aggressively stimulate the eye
and have the same effect. A number of eye illnesses can be triggered or
aggravated by eye fatigue1. During the COVID-19 pandemic, there was
an increase in the usage of digital gadgets, which increased the likelihood of
acquiring symptoms connected to digital eye strain.2 In eye fatigue, the
ciliary muscles and the extraocular muscles are strained and cause discomfort,
soreness or pain in the eyeballs3. This is due to the fact that eye weariness
necessitates excessive use of the ciliary and extraocular muscles, which can
result in eye fatigue and other associated symptoms4 in a
nonpresbyopic population, ocular fatigue and asthenopic symptoms which are the
most often reported conditions and very important.5 |