| CTRI Number |
CTRI/2024/07/071218 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Yoga & Naturopathy Preventive |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Discovering the Mind-Body Benefits of Trataka: A Preliminary Study on Yogas Impact on Eye Health and Neurology |
|
Scientific Title of Study
|
Exploring the neurophysiological effects of trataka as a
yogic neuro ophthalmic examination technique within Ayurveda interventions A pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma N S |
| Designation |
Associate Professor and Research Officer |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Room No. 407, Dept of ACARA, Amrita School of Ayurveda, Amritapuri, Clappana P.O
Kollam KERALA 690525 India |
| Phone |
|
| Fax |
|
| Email |
sushma@ay.amrita.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Sushma N S |
| Designation |
Associate Professor and Research Officer |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Room No. 407, Dept. of ACARA, Amrita School of Ayurveda, Amritapuri, Clappana P.O
Kollam KERALA 690525 India |
| Phone |
|
| Fax |
|
| Email |
sushma@ay.amrita.edu |
|
Details of Contact Person Public Query
|
| Name |
Sushma N S |
| Designation |
Associate Professor and Research Officer |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Room No. 407, Dept. of ACARA, Amrita School of Ayurveda, Amritapuri, Clappana P.O
Kollam KERALA 690525 India |
| Phone |
|
| Fax |
|
| Email |
sushma@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda and Hospital |
|
|
Primary Sponsor
|
| Name |
Amrita Vishwa Vidyapeetham |
| Address |
Amrita Vishwa Vidyapeetham
Vallikavu
Clappana PO
Kollam
Kerala |
| Type of Sponsor |
Other [Private University] |
|
|
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 Sushma N S |
Amrita School of Ayurveda and Hospital |
Room No. 407, Dept. of ACARA, Amrita school of Ayurveda Amritapuri Clappana PO Kollam KERALA |
08589063046
sushma@ay.amrita.edu |
|
|
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 |
| Patients |
(1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Trataka, Ritucarya: no, Acara Rasayana:no, Other:no, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers aged 18 to 25 who have not previously practiced YVC procedure and with Eye Fatigue score exceeding 1will be included in the study |
|
| ExclusionCriteria |
| Details |
Volunteers with frequent symptoms of headache watering of eyes ocular pain chronic systemic illness color blindness any known neurological or psychiatric disorders lenticular or corneal opacity or retinal pathology |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Publications on the effects of YVC on mind wandering and cognitive function using EEG
Assessment of YVCs impact on dispositional mindfulness cognitive impairment and eye fatigue
Identification of potential neural correlates for neurological and ocular pathologies
Facilitation of rehabilitation plans and treatment strategies for stress and eye conditions
Creation of evidence and clarity on YVCs mechanism and cost effective stress reduction technique |
Year 1

EC clearance 

Appointment of SRF 

CTRI registration 

Set up trial setting 

Patient recruitment and training for YVC procedure
Data measurement 

EEG measurement analysis and interpretation 

Year 2

Data compilation 
 Statistical and Machine learning analysis 

Interpretation of the results

Study conclusion 

Conduction of awareness programs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Promotion of YVC as a healing technique from the IKS
Publication of study findings in journals
Conducting Pan India Neuro-Ayurveda Yoga Symposia on YVC and its impact
Submission of proposals based on this study data to other funding agencies |
year 2 |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- 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 [sushma@ay.amrita.edu].
- For how long will this data be available start date provided 04-05-2024 and end date provided 01-04-2031?
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
|
This project aligns with SDG 3 which targets good health and wellbeing for all Yogic visual concentration YVC is one of the procedures adopted from the Yoga Shastra The government is very keen on promoting the wisdom of Indian Knowledge Systems especially in healthcare It is a way of integrating traditional sciences with modern sciences A profound statement from Canakyas Nitishatakam states that of all the five sense organs eyes are the most important and valuable It is also quite understandable that a significant amount of inputs are visual
About 80 percent of the brains sensory information is from the eyes and eye fatigue has become common because of the use of digital devices Mind wandering frequently occurs when the thought switches from an ongoing task and or an external stimulus driven event to self generated or inner thoughts Pre occupation is a common symptom that arises and consequently mind wandering follows A network of neurons called the default mode network DMN in the brain has been associated with mind wandering and is most active when a person is resting and is associated with memory retrieval The brain processes the acquired knowledge through the senses and synchronises all the electrical activity that is constantly received and generated through the eye A focused study on how YVC is perceived in its nature of modifying or intent to actions is yet to be undertaken There are several references of YVC in classical texts of Yoga Sastra such as the Hatayoga Pradipika and Gheranda Samhita which are mentioned as one among the Sat Kriya the six procedures to purify the body A quote from an Ayurveda treatise Charaka Saṃhita states that the mind plays a vital role in adequately conducting sense organs and enables them to gather inputs In the same text it is mentioned Buddhim apyayati and Buddhim upaghataya in Hina and Mithya Yoga of the sensory organ suggesting a connection between Buddhi Manas and Indriya In practice Ayurvedic clinicians commonly employ this technique for various eye disorders including eye fatigue and numerous conditions related to retinal pathology The Hatayoga Pradeepika cites Mochanam netra roganam tandradeenam kapatakam. Yatnas tat tratakam gopyam yatha hataka petakam indicating its efficacy in treating eye diseases Our focus initially revolves around eye fatigue related conditions Tandradi Here Trataka is linked to the concept of Vyayama in Ayurveda Building upon this understanding our goal is to establish the connection between the eye as the sensory organ and the brain or Buddhi through EEG analysis This will enable us to gain insights into the brain activities occurring during the Trataka technique as this in particular is focused on benefiting mental concentration and thereby helps in dealing with activities being more focused Preliminary information from the literature suggests improvement in selective attention response inhibition cognitive flexibility Sherlee 2020 and critical fusion frequency following YVC sessions Mallick 2010 and the technique had impacts on patients with insomnia and anxiety Shathirapathiy 2022 A study suggested it reduces visual strain due to prolonged exposure to digital displays Saoji 2022 The technique has some benefits to pathologies including primary open angle glaucoma POAG Ismail 2021 Myopia Ametropia and Presbyopia Gopinathan 2012 When practitioners report that such techniques influence their well being that may indicate that the ability to perform future actions are better and cortical activation regions could show a neural correlate to this effect We would like to explore why ophthalmology studies in Ayurveda use this method not just as a stress reduction or patient relaxation technique but are added to as a treatment component To this goal we will study synchrony and network dynamics healthy and experimental group of volunteers who perform exercises and YVC and possibly differentiate changes in cortical temporal and spatial components To complement this study will also explore variations of possible biosignatures among patients with eye conditions The second objective is based on our experience with epilepsy studies Parasuram 2021 Altogether the role of the eye and the mind is very much interlinked and the impact is on both the health of the eye and mental health YVC is a cleansing technique and the final stage of YVC induces a meditative mental state which when practised over time improves perception attention and cognition Many research studies have shown improvement in attentional task performance following meditation This project will highlight a simple yet uncommon Yogic practice used in Ayurvedic therapies exploring systemic and local effects using EEG analysis on eye fatigue dispositional mindfulness and cognitive impairment in addressing eye and mental health as a novel attempt In principle this proposal addresses questions such as What is the influence of YVC and its impact on cortical activity Can neural underpinnings reveal Ayurvedas subjective and objective assessment of eye disorders We will explore and report synchrony potential cortical changes and activation patterns for YVC The study will be attributed to the great visionaries of Indian Heritage These seers introduced this simple concept of YVC yielding benefits such as focused concentration and maintenance of ocular and mental health |