| CTRI Number |
CTRI/2024/05/066908 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of trataka and eye exercise on myopic patient |
|
Scientific Title of Study
|
Effect of Bahiranga Trataka Kriya and Bates eye exercise
on Refractive Error in patients with myopia – A Randomized
Clinical 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 |
Sandeep kumar gupta |
| Designation |
PG student |
| Affiliation |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy Yogic Sciences. |
| Address |
Zp-77Ground Floor, Sector-Zp, Sushant City Meerut
Meerut UTTAR PRADESH 250002 India |
| Phone |
7860134487 |
| Fax |
|
| Email |
skg754709@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy Yogic Sciences. |
| Address |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy Yogic Sciences.
CSSH, SVSU
Meerut UTTAR PRADESH 250002 India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR ABHAY M SHANKAR GOWDA |
| Designation |
PRINCIPAL |
| Affiliation |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy Yogic Sciences. |
| Address |
Swami Vivekanand Subharti University
Subhartipuram, NH.58, Delhi-Haridwar Bypass Road,
Meerut
Meerut
UTTAR PRADESH
Meerut UTTAR PRADESH 250002 India |
| Phone |
9448300347 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Dr. Sandeep Kumar Gupta, Pg Department, Maharishi Aurobindo Subharti College And Hospital Of Naturopathy Yogic Sciences, Swami Vivekanand Subharti university, Subhartipuram NH58 delhi haridwar bypass meerut uttar pradesh 250005 |
|
|
Primary Sponsor
|
| Name |
Sandeep Kumar Gupta |
| Address |
Zp-77Ground Floor Sector-Zp Sushant City Meerut |
| 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 |
| Sandeep Kumar Gupta |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy And Yogic Science, CSSH, SVSU |
Swami Vivekanand Subharti University
Subhartipuram, NH.58, Delhi-Haridwar Bypass Road,
Meerut
Meerut UTTAR PRADESH |
7860134487
skg754709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UECM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bahiranga trataka kriya |
The Bahiranga trataka kriya is practised in a room that is completely
dark and free of draughts and insects.
• Put a candle at eye level two to three feet in front of you.
The flame must be completely steady and flickering at all times.
• Sit in a relaxed meditation position, ideally in siddhasana, and place
your hands in the jnana mudra position on your knees.
• Become fully relaxed. As with any meditation practise, close your eyes
and get ready.
• Make yourself peaceful and silent, and prepare to maintain complete
stillness for the entire practise.
• Spend some time practising kaya Sthairyam (body steadiness). Then
open your eyes and look at the candles middle section, which is just
above the wick.
• Try not to blink and maintain a completely steady gaze.
• If the eye becomes uncomfortable or fatigued, drop the eyelids.
• Stare for as long as you can for five minutes, or for longer if you can do it without closing your eyes.
• Only when absolutely necessary should one close their eyes.
• If any thoughts arise, push them out of the mind as soon as they do.
• Throughout the entire practise, Sakshi should remain a silent observer.
• When you do finally close your eyes, keep them centred on the image
of the flame in Chidakasha in front of you.
• If it shifts, bring it back to the centre and keep staring at it until the
impression goes away.
• As soon as you can do so, stabilise the image and carefully examine the
colour.
• Sometimes you might not see light, but rather an impression that is
even darker than Chidakasha.
• Keep your thoughts absolutely absent. Just focus on that one thing at a
time.
• Let thoughts come and go, and dont get caught up in them.
• Unless the guru has instructed you to practise for a longer period of
time, practise for fifteen to twenty minutes.
• Trataka are performed first thing in the morning while fasting.
• On an empty stomach, a positive outcome will occur.
• imagine breathing in and out of the Ajna chakra through the mindeyebrow centre if your eyes are feeling heavy.
• Continue to be conscious of your breathing as you close your eyes and
look at the counter-image, breathing into and out of the image via the
centre of your brow
one session per day for total 30 days |
| Comparator Agent |
BATES EYE EXERCISE |
The bates eye exercise is practised in a room that is completely dark
and free of draughts and insects.
• Sit in a relaxed meditation position, ideally in siddhasana, and place
your hands in the jnana mudra position on your knees Become fully
relaxed.
• As with any meditation practise, close your eyes and get ready.
• Make yourself peaceful and silent, and prepare to maintain complete
stillness for the entire practise.
• Gently rub you both the hand and when palm become heat the patient
gently covers the closed eyes with the palms of their hands to provide
complete darkness and feels heat on your eye ball aiding relaxation.
• The colours, shades of colour and the phenomena "seen" by the patient
while palming are apparently of diagnostic value cup your hands over
your eyes, so that no light gets into the eyes, and rest the arms on a
table or pillow for comfort.
• Now try to imagine pure darkness and relax the eyes. Rest in this
palming posture for at least 5 minutes . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild To Moderate Myopic Patients
2. Willing To Participate |
|
| ExclusionCriteria |
| Details |
Patient undergone recent eye surgery
• Corneal opacity
• Ocular pathology
• Diabetic retinopathy
• Patient with high myopia
• Glaucoma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Retinoscope
Autorefractometer |
baseline and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Functioning Questionnaire – 25 |
baseline & 4 week |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="129" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/07/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In 2010, 1.45 billion people, or 27% of the world’s population, had myopia, which is defined as having a myopia of more than or equal to 0.50 D. Myopia is the most common cause of distance refractive error globally. India is the second-most populous nation in the world, with 492 million people, or about 41% of its total population, under the age of 18. The issues faced by this youthful generation must be promptly addressed because they are a valuable resource for the growth of the country. The human eye collects light rays as they pass through the retina and converts them into an image. However, in myopia, light rays fall in front of the retina, creating visual blurring. One of the three often seen refractive defects, along with hypermetropia (long-sightedness) and astigmatism, is myopia, also known as near-sightedness or short-sightedness When the light rays entering the eye are improperly focused onto the retina, refractive errors arise. When a person has myopia, light rays entering the eye fall in front of the retina, making distant objects look blurry while near items can be 6 seen clearly. Currently available treatments for decreasing the growth of myopia include spectacle lenses, contact lenses, and pharmacological medications. pharmacological agents Recent well-designed studies using 0.5% atropine, a non-selective muscarinic antagonist, with multi-focal glasses (0.41 D) compared to multi-focal glasses alone (1.19 D) or SVLs alone (1.40 D), demonstrated statistically and clinically significant reductions in the progression of myopia. drastically reduces.Complementary and alternative medicine (CAM) a range of several medical and health care systems includes Ayurveda, which has roots in ancient India more than 5,000 years, emphasises a specific treatment based on each patient’s circumstances. It involves therapies such as yoga, meditation, naturopathy, massage, nutrition, and herbal remedies, use extremely small amounts of a drug that induces symptoms in order to activate the body’s natural healing process. Trataka, which means "to look at or gaze," is a preparatory practise for meditation that entails fixating on a single point, such as a small item, a black dot, or a candle flame. The Bates method, established by New York ophthalmologist William Horatio Bates (1860-1931), is one of the most extensively utilised eye exercises for alternative therapies. According to Dr William Bates, the most crucial aspect in getting optimal visual acuity at varied distances is to achieve a state of complete relaxation. Proper eye motions allow patients’ eyes to rest, moisturise, and massage. Palming, visualisation, movement (or ‘shifting’, and sunbathing are all part of the Bates method). Previous research has found that combining yoga practises(Near and far focusing with Kapalbhati), with other eye relaxing techniques can improve visual acuity. Therefore it is necessary to conduct a study so that the research gap can be fullfilled. 90% data collection has been done. |