| CTRI Number |
CTRI/2025/02/079873 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Interventions like Jyotir and Bindu Trataka for young adults participants to assess the cognitive functions |
|
Scientific Title of Study
|
EVALUATING THE EFFECT OF JYOTIR TRATAKA AND BINDU
TRATAKA ON COGNITIVE FUNCTIONS OF YOUNG ADULTS –A
RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagashabdha V S |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu. |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block , 1st Floor ,Department of Yoga, Kamarajar Nagar,Chengalpattu,Kancheepuram,Tamilnadu-603001,India
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9629052951 |
| Fax |
|
| Email |
drnagashabdha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr A Gayathri |
| Designation |
Head of Department-Yoga |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu. |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block , 1st Floor ,Department of Yoga, Kamarajar Nagar,Chengalpattu,Kancheepuram,Tamilnadu-603001,India
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nagashabdha V S |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu. |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block , 1st Floor ,Department of Yoga, Kamarajar Nagar,Chengalpattu,Kancheepuram,Tamilnadu-603001,India
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9629052951 |
| Fax |
|
| Email |
drnagashabdha@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu-603001 |
|
|
Primary Sponsor
|
| Name |
Dr Nagashabdha V S |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block , 1st Floor ,Department of Yoga, Kamarajar Nagar,Chengalpattu,Kancheepuram,Tamilnadu-603001,India |
| Type of Sponsor |
Other [Self] |
|
|
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 Nagashabdha V S |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(1st Floor) ,Department of Yoga, Kamarajar Nagar,Chengalpattu Kancheepuram TAMIL NADU |
09629052951
drnagashabdha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Trataka for Improvement on Cognitive Functions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bindu Trataka |
Bindu Trataka-The study participants will receive one day of orientation program before the trial.
Subjects will be advised to sit in Sukasana with the head and spine straight and the
hands resting on the kneesin chin mudra. Close the eyes and relax the whole body
for few minutes. A dot of ¼ th inch size is used as the object to be observed. A dot is
made on paper and placed at an 3 feet distance and the patient is advised to focus on
that bindu untiltear starts coming from his/her eyes.
|
| Comparator Agent |
Control Group |
In the control group, participants will receive no specific intervention and will simply continue with their usual daily routines. This group will serve as a baseline, allowing for the assessment of natural cognitive changes over time, without the influence of any external practices or techniques. |
| Intervention |
Jyotir Trataka
|
Jyotir Trataka-The study participants will receive one day of orientation program before the trial. Subjects
will beadvised tosit in sukasana with the head and spine straight and the hands resting on the
knees in chinmudra. Jyotir Trataka have four steps and candle is placed at an 3 feet distance
and the patient is advised to focus on the candle light until tear starts coming from his /her
eyes.
Step 1-Effortless gazing or Focusing at flame
Step 2 –Intensive Focusing at the tip of the wick of the flame
Step 3-De-Focusing
Step 4-Silence
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy participants who are willing to give their consent.
Those who have underwent systemic health check-up by a trained
physician, who otherwise had no role in the study. |
|
| ExclusionCriteria |
| Details |
Participants with psychiatric illness, neurological conditions &
systemic illness. Surgical history, Injuries and epilepsy.
Individuals with Refractive errors.
Pregnant and lactating women.
Individuals Practicing Yoga |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CRITICAL FLICKER FUSION FREQUENCY (CFFF) |
Assessment of Critical Flicker Fusion before staring the study and after completing the study(2 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SIX LETTER CANCELLATION (SLCT) |
Assessment of Six Letter Cancellation before staring the study and after completing the study(2 weeks) |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
10/02/2025 |
| 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="1" Days="10" |
|
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 - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 01-01-2026 and end date provided 02-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The term "cognitive functioning" describes a variety of mental processes such as learning, reasoning, thinking, remembering, solving problems, making decisions, and paying attention. Attention and memoryare essential aspects of cognitive health.Various aspects of cognition, such as spatial and visual memory scores ,verbal memory, executive functions, attention, and concentration , working memory, response inhibition ,visual attention , and task-switching were found to be positively influenced through yogic practices such as yogasanas, pranayama, and meditation techniques.Memory is an active system that receives information from the senses, puts it into a usable form, organizes it as it stores away, and retrieves the information from the storage. Short-term memory (STM) is a system in which information is held for brief periods while being used. It lasts from about 20 to 30 seconds without rehearsal.After that, the memory seems to rapidly decay or disappear. It (primary memory) involves conscious maintenance of sensory stimuli over a short period even after which they are not present anymore.Short Term Memory is an essential component of cognition as it influences efficient performance of day to day activities.Multistore models differentiate between STM. Regular practice of yoga promotes strength, endurance, flexibility and facilitates characteristics of compassion, greater self-control, while cultivating a sense of calmness and well being.Yoga is a form of mind-body fitness that involves a combination of muscular activity and internally directed mindful focus on awareness of the self, the breath and energy(8).Shatkarma also called as shatkriyas ‘Shat’’ means ‘six ‘and karma means ‘action’ are a series of purifying Hatha Yoga poses for the body that prepares it for the ultimate yoga practice in relation to moksha(liberation).The sansrit, shatkarmas are six actual acts. These practices includes-Dhauti, Nauli, Basti, Kapalabhati and Trataka are referred to as kriya by swatmarama in the Hatha Yoga Pradipika. Hatha Yoga , is made up of shatkarmas. The aim of the hatha yoga and ,therefore ,of the shatkarma is to create harmony between the two major pranic flows, Ida and pingala, therby attaining physical and mental purification and balance. Trataka, one of the six purification techniques is included in the study. Also called yogic gazing is a practice where the gaze is fixed on an object for some time and then that the object is visualized clearly with the eyes closed, as an inner image at the eyebrow centre. The practice makes eyes bright and clear. It improves the memory and helps to develop good concentration and strong will power Trataka means to gaze steadily .At the physical level it is said to strengthen the eye muscles by exercising them to focus upon a point.Trataka can be performed in two forms-Bindu Trataka and Jyotir Trataka.In Bindu Trataka a dot is made on paper and placed at an appropriate distance and the practitioner is advised to focus on that bindu until tear starts coming from his/her eyes ,Bindu trataka is easy to focus on something which is not illuminated and rather provides a soothing effect to the eyes.In Jyotir trataka the practitioner is advised to gaze at the candle light until tear starts coming from his/her eyes. The overindulgence in digital media has become a major social Issue, and its profound impact on our daily routines and lifestyle choices has been acknowledged by everybody. Furthermore, the bulk of social media users are young adults 84% of adults between the ages of 18 and 29 report having downloaded a social networking app, according to the Pew Research Centre. Users of this kind of media receive a dopamine reward when they swipe and scroll, which over time builds an addiction pathway that impairs impulse control in the prefrontal brain. The desire to continue scrolling or open Instagram during a boring meeting is caused by a combination of inhibition and dopamine. This is especially true for persons under the age of twenty-one, whose developing prefrontal cortices make them more prone to dopamine surges and impulsivity . Research suggests trataka technique increases selective attention, cognitive flexibility, and response inhibition. Yoga practice was found to be better than physical exercises in improving cognitive functions.In this study we have selected college going students of age 18 to 25 years as they need better Cognition functions . |