| CTRI Number |
CTRI/2013/06/003727 [Registered on: 07/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/11/2019 |
| 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 on attention, concentration, memory and executive functions in the elderly |
|
Scientific Title of Study
|
Effect of Trataka on cognitive functions in the elderly |
| Trial Acronym |
TCE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Jagannathan |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)- Institute |
| Address |
Swami Vivekananda Yoga Anusandhana Samasthana (SVYASA),
# 19, ‘Eknath Bhavan’, Gavipuram Circle,
Kempe Gowda Nagar, Bengaluru
Bangalore
KARNATAKA
560019
India |
| Phone |
9448150690 |
| Fax |
|
| Email |
jaganaarti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhada S Talwadkar |
| Designation |
Research Scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)- Institute |
| Address |
No.19, Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bangalore
Bangalore
KARNATAKA
560019
India |
| Phone |
8147612062 |
| Fax |
|
| Email |
shubhadatalwadkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhada S Talwadkar |
| Designation |
Research Scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)- Institute |
| Address |
No.19, Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bangalore
Bangalore
KARNATAKA
560019
India |
| Phone |
8147612062 |
| Fax |
|
| Email |
shubhadatalwadkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| No source of monetary or material support. Study part of MD thesis submitted to Swami Vivekananda Yoga Anusandhana Samasthana (SVYASA,Bangalore, India |
|
|
Primary Sponsor
|
| Name |
Shubhada S Talwadkar |
| Address |
No. 19, Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bangalore - 560 019 |
| Type of Sponsor |
Other [Self sponsorship] |
|
|
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 |
| Shubhada S Talwadkar |
Swami Vivekananda Yoga Anusandhana Samsthana SVYASA |
No. 19, Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bangalore Pin- 560 019
Bangalore
KARNATAKA |
8147612062
shubhadatalwadkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVYASA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trataka |
Trataka was provided for 1 month daily for 1 hour each day to the participants. First step is the up and down or vertical movement of the eyes. In all the practices one has to open the eyes and move the eyeballs gently. It has to be smooth and continuous without any jerky movement. This has to be repeated for ten rounds. After the practice to relax the eyes simple palming is given, that is, rub the palms and then make a cup of it and cover the eyeballs. The second step is right and left or horizontal movements of eyeballs. Here, after opening the eyes one has to move the eyeballs to left and right. Again this also has to repeated ten rounds. Here also simple palming has to be given. The next step is diagonal movement of eyeballs. Here the eye balls has to be moved extreme right up and extreme left down for ten rounds. After that press and release palming has to be given. That is as one inhale press the palms around the eyes and as one exhale release the pressure. It has to be continued for 10 rounds. Fourth practice is diagonal movement in the opposite direction. The relaxation is by same press and release palming. Next step is rotational movement of the eyeballs that is clockwise and anti clockwise. Here after the practice for relaxation the constant pressure palming has to be done. That is press constantly around the eyeballs with the palms with inhalation and release with exhalation.
After the preparatory exercises next is jyoti trataka, and it has three steps. In that first is focusing, that is effortless gazing or focusing at a flame. One has to look at it for 30 seconds. After the practice for relaxing press and release palming has to be given.
Next step is intensive focusing at the tip of the wick of the flame. Here constant pressure palming has to be given after the practice. Then the next step is de-focusing. That is first look at the flame then slowly widen the vision and have a defocused gaze on the flame with expansive awareness and collect the details of the flame. After one minute again focus on the flame then slowly close the eyes and try to visualize the flame between the eyebrows and collect all details with eyes closed. When the image disappears go for palming with chanting of Bhramari. Then come to the last step that is silence. Feel the silence and relax for a while. |
| Comparator Agent |
Wait list Control |
The wait list control group were not given any intervention for the entire duration of the study (1 month) |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subjects
2. Education: 5th std and above
3. Willing to participate by giving a written informed consent.
4. Those knowing Konkani, Hindi, English, Marathi.
|
|
| ExclusionCriteria |
| Details |
1. Those having neurological and psychiatric disorders
2. Those who have practiced yoga for the last 3 months.
3. No major eyesight problems (in vision)
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Working memory |
Assessed at Baseline (Day 0), immediately post
intervention on Day 1, and after completion of 1
month of intervention from baseline (Day 27). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Working memory |
Assessed at Baseline (Day 0), immediately post intervention on Day 1, and after completion of i1 month of intervention from baseline (Day 27. |
| Executive functioning |
Assessed at Baseline (Day 0), immediately post intervention on Day 1, and after completion of i1 month of intervention from baseline (Day 27. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/02/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
Modification(s)
|
1.Talwadkar S, Jagannathan A and Nagarathna R. Effect of Trataka on cognitive functions in the elderly. International J Yoga 2014 July; 7 (2) :96-103
2. Talwadkar S, Jagannathan A and Nagarathna R. Response to ‘Trataka and cognitive function’. International J Yoga 2015 Jan; 8 (1): 83. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized controlled, parallel group study to test the effect of trataka on cognitive functions of elderly . A one month, one hour trataka ( yoga) programme was provided to 60 (using quota sampling) consenting elderly, who were recruited from 4 old-age homes in Goa. The elderly in groups of 20 and matched on language were randomized into one of the two groups: Trataka (N=34) and wait-list control (N=26). 12 elderly (8 from the intervention group and 4 from the control group) did not complete the 1 month study period. Outcome measures (attention - concentration, working memory and executive functioning) were collected at the start of the study (baseline - day 0), immediately after Day 1 of intervention and 1 month post intervention (Day 27). The intervention group was provided trataka by an experienced and qualified yoga professional for the 1 month period of the intervention and the waist list control group was not provided any intervention for the 1 month period. Those in wait-list control group, interested in undergoing trataka treatment were however offered the intervention after the completion of the study (Post Day 27).
|