| CTRI Number |
CTRI/2018/05/013764 [Registered on: 08/05/2018] Trial Registered Prospectively |
| Last Modified On: |
27/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of Left Nostril Breathing Technique on Cognition, a higher mental function in healthy individuals. |
|
Scientific Title of Study
|
A Randomized, Controlled Study of Effect of Unilateral Left Nostril Breathing on Cognitive Function in healthy Yoga-Naive individuals. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Suvethasri SK |
| Designation |
6th semester MBBS Student |
| Affiliation |
|
| Address |
Kasturba Medical College, Lighthouse Hill Road, Hampankatta, Mangalore
Room Number 6A, Nandagiri Ladies Hostel, Lighthouse Hill Road, Hampankatta , Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
shwethakumar82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sai Suvethasri SK |
| Designation |
6th semester MBBS Student |
| Affiliation |
|
| Address |
Kasturba Medical College, Lighthouse Hill Road, Hampankatta, Mangalore
Room Number 6A, Nandagiri Ladies Hostel, Lighthouse Hill Road, Hampankatta , Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
shwethakumar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sai Suvethasri SK |
| Designation |
6th semester MBBS Student |
| Affiliation |
|
| Address |
Kasturba Medical College, Lighthouse Hill Road, Hampankatta, Mangalore
Room Number 6A, Nandagiri Ladies Hostel, Lighthouse Hill Road, Hampankatta , Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
shwethakumar82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Lighthouse Hill Road, Hampankatta, Mangalore-575001 |
|
|
Primary Sponsor
|
| Name |
Sai Suvethasri SK |
| Address |
Lighthouse Hill Road, Hampankatta, Mangalore |
| 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 |
| Sai Suvethasri SK |
Kasturba Medical College, Mangalore |
Pharmacology Laboratory
Department of Pharmacology Lighthouse Hill Road, Hampankatta, Mangalore-575001
Dakshina Kannada
KARNATAKA |
9789807054
shwethakumar82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College, Mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy yoga-naive individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing Exercise |
Duration- 15 minutes
Mode of administration - Unilateral left nostril breathing exercise. |
| Comparator Agent |
No breathing exercise |
Duration -15 minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who are willing to provide Informed Consent and to follow the study procedures. |
|
| ExclusionCriteria |
| Details |
1. Individuals practicing any form of yoga
2. Individuals with any acute or chronic illness at the time of participation
3. Individuals with a history of intake of any medication within a week prior to participation in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on Attention and processing speed, Memory and Executive function |
15 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/05/2018 |
| Date of Study Completion (India) |
25/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomized, Controlled, Parallel-group study on healthy Yoga-naive individuals to assess the effects of unilateral left nostril breathing technique on cognitive functions. The primary outcome measures include attention and processing speed, memory and executive function following a period of 15 minutes of the breathing technique and breath awareness in the test and control groups, respectively. The sample size will be a total of 20 participants. |