| CTRI Number |
CTRI/2024/12/078650 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of pranayama on attention and arousal in patients with type 2 diabetes |
|
Scientific Title of Study
|
Effects of two specific yoga breathing techniques on measures of attention and arousal in patients with Type 2 diabetes: a pilot randomized control 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 Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL |
| Type of Sponsor |
Research institution |
|
|
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 Shirley Telles |
Patanjali Research Foundation (Trust) |
Clinical Neurophysiology Lab, Department of Yoga Research, 2nd Floor Sadbhawana Building, Patanjali Yogapeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL |
9897963254
shirleytelles@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Department of Yoga Research, Patanjali Research Foundation (Trust) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bhastrika |
The duration of intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Comparator Agent |
Breath awareness |
The duration of intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Intervention |
Bumblebee (Bhramari) yoga breathing |
The duration of intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Comparator Agent |
Quiet Sitting |
The duration of intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
(i) patients with type 2 diabetes
(ii) Age range 30 to 50 years
(iii) Normal hearing
|
|
| ExclusionCriteria |
| Details |
((i) Patients with cognitive problems based on mini mental state examination (MMSE) (ii) Patients with tinnitus(iii) Person with extra systole based on electrocardiogram (ECG) (iv) Any respiratory problem |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(i)P300 ERP
(ii)Heart rate variability (HRV) and Respiration rate (RR) |
(i)At baseline and after 17 minutes of intervention or control sessions
(ii) Before, during and after intervention or control sessions
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) Six letter cancellation test, (ii) Mood states (BMIS),
(iii) Randomized Blood Sugar(RBS),
|
(i) Before and after intervention or control sessions
(ii) Before and after intervention or control sessions
(iii) Before intervention or control sessions
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The aim of this study is to (i) assess the effects of the specific yoga breathing practices on attention and arousal in patients with type 2 diabetes and (ii) determine whether 7 days of residential yoga and allied therapy program can enhance the effect of yoga breathing practices on attention and arousal in patients with type 2 diabetes |