| CTRI Number |
CTRI/2024/09/074100 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Blue Color light and candle gazing on Insomnia patient. |
|
Scientific Title of Study
|
Effect of Blue Light Therapy and Trataka on Insomnia Patients- A Comparative 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 |
Abhijith M |
| Designation |
Junior resident student |
| Affiliation |
Rajiv Gandhi university of health and sciences |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady.
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9207073430 |
| Fax |
|
| Email |
abhijithnechur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhijith M |
| Designation |
Junior resident student |
| Affiliation |
Rajiv Gandhi university of health and sciences |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady.
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9207073430 |
| Fax |
|
| Email |
abhijithnechur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yohi T H |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi university of health and sciences |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9842696017 |
| Fax |
|
| Email |
thyohi19@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Yoga and nature cure hospital Shanthivana, Dharmasthala, Belthangady, Karnataka, India.
Pincode- 574240 |
|
|
Primary Sponsor
|
| Name |
Abhijith M |
| Address |
SDM college of Naturopathy and Yogic Sciences, Ujire, Belthangady,
karnataka, India pincode-574240 |
| 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 Yohi T H |
SDM Yoga and Nature Cure Hospital |
Tejas yoga hall, SDM yoga
and nature cure
hospital, Shanthivana, Dharmasthala.
pincode-574216
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9842696017
thyohi19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmastala manjunatheshwara Naturopathy and Yoga Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Blue light therapy |
Duration- 20 minutes for 10 days in the evening.
Procedure:
Patients undergoing the therapy are provided with blue light bulb emitting a wavelength of 450nm and instructed to spend 20 minutes in a room illuminated by the blue light. During this session, they are encouraged to relax either on a bed or on the floor with the mat, while also being advised to avoid any unwanted disturbance for optimal results. |
| Intervention |
Trataka |
duration: 30 minutes for 10 days in the Evening.
Procedure:
Light the candle, then settle into your chosen posture and rest the hands either on the legs, or the abdomen — whichever feels more calming for you in this moment.
Close the eyes, and take ten deep breaths through the nose. Aim to make the exhale twice as long as the inhale; for example, inhaling for a count of three, and exhaling for a count of six. Allow yourself to slow down and be in this moment.
Open the eyes and immediately fix your gaze on the candle flame. Focus on the point right at the tip of the wick, where the flame is strongest and brightest.
Do not blink—the eyes remain open for as long as possible. Your eyes may start to water and you’ll want to blink, but hold the focus until you can’t any longer.
When you can’t keep the eyes open anymore, relax all of those muscles that have worked to keep them focused, and allow the eyes to close. Hold the image of the candle flame in your mind; it’s as if that image is being projected in between the eyebrows.
When the image has faded, you’ve completed one round of trataka.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Those who are having sleeplessness in the past 15 days
subjects willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
subjects history of mental illness.
Females subjects under menstruation.
Patients who are consuming alcohol and smoking prior to beginnning of study.
Currently using slepp medication.
Visual impairments or photosensitivity.
Weak and debiliating patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity Index (ISI) |
baseline taken for period of 10 days before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Mayyo Sleep Questionnaire (MSQ) |
baseline taken for period of 10 days before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/09/2024 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
EFFECT OF BLUE LIGHT THERAPY AND TRATAKA ON INSOMNIA PATIENTS - A COMPARTIVE STUDY
METHOD: Group 1 (n=30) : trataka is given for 30 minutes for 10 days Group 2(n=30): blue light therapy is given for 20 minutes for 10 days. Group 3 (n=30): no intervention
OUTCOME VARIABLE: Primary outcome: Insomnia Severity Index (ISI) Secondary outcome: The Mayyo Sleep Questionnaire (MSQ)
Data will be collected at the baseline before starting and after 10 days of intervention . |