| CTRI Number |
CTRI/2024/09/073525 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Brahmari and Nadishodhana pranayama for sleep improvement in Geriatric group |
|
Scientific Title of Study
|
A COMPARITIVE STUDY TO EVALUATE THE EFFECT OF BHRAMARI PRANAYAMA AND NADISHODHANA PRANAYAMA ON QUALITY OF SLEEP AMONG GERIATRIC AGE GROUP |
| 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 MaryThabitha ET |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Ayurveda And Hospital Udupi |
| Address |
Department of Swasthavritta
Shri Dharmasthala Manjunatheshwara College of Ayurveda
Kuthpady, Udyavara
Kuthpady, Udyavara
Udupi
KARNATAKA
574118
India |
| Phone |
8594053729 |
| Fax |
|
| Email |
marythabitha743@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVijay B Negalur |
| Designation |
HOD ,Professor |
| Affiliation |
SDM College of Ayurveda And Hospital Udupi |
| Address |
Department of Swathavritta
Shri Dharmasthala Manjunatheshwara College of Ayurveda
Kuthpady, Udyavara
Udupi
KARNATAKA
574118
India |
| Phone |
7892618108 |
| Fax |
|
| Email |
drvijaynegalur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MaryThabitha ET |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Ayurveda And Hospital Udupi |
| Address |
Department of Swathavritta
Shri Dharmasthala Manjunatheshwara College of Ayurveda
Kuthpady, Udyavara
Udupi
KARNATAKA
574118
India |
| Phone |
8594053729 |
| Fax |
|
| Email |
marythabitha743@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital Kuthpady UDUPI, Karnataka ,Pin 574118 , India |
|
|
Primary Sponsor
|
| Name |
DrMary Thabitha E T |
| Address |
Shri Dharmasthala Manjunatheshwara College Hospital and Research Center Kuthpady Udupi pin 574118 |
| 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 Mary Thabitha E T |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital ,Kuthpady,Udupi |
OPD AND IPD Of Department of Swasthavritta SDM College of ayurveda and hospital,Kuthpady, Udupi
Udupi
KARNATAKA |
8594053729
marythabitha743@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE -HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric age group of 60-75 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brahmari pranayama |
30 samples of Geriatric age group of 60-75 years will be selected for doing the Brahmari pranayama as a comparative agent for the duration of 30 days and the assessment will be done on 0th day,15th day and 30th day. |
| Intervention |
Nadishodhana pranayama |
30 samples of Geriatric age group of 60-75 years will be selecting for doing the intervention Nadishodhana for the duration of 30 days and the assessment will be done on 0th day,15th day and 30th day. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Those who are 60-75 years old and mentally fit, can able to follow the command
Subjects who are willing to give the consent.
|
|
| ExclusionCriteria |
| Details |
Those who are unable to follow the command.
Those who are under the medications of psychosomatic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 30 Samples which will be selecting for the intervention group Nadishodana pranayama for assessing the improvement of sleep quality by doing Nadishodana pranayama. The changes felt by the subjects will be assessed by using PSQI scale. And comparing it with the standard group Bhrahmari pranayama. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/09/2024 |
| 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="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
|
This study is an Comparative clinical study to evaluate the effect of Brahmari pranayama and Nadishodana pranayama on quality of sleep in geriatric age group. The patients will be randomly divided into 2 groups each group of 30 participants. Total participants of 60.Group A recruited subjects will be administered with Nadishodana pranayama and Group B recruited subjects will be administered with Brahmari pranayama.Total duration of study will be 30 days . Study will be conducted at Shri Dharmasthala Manjunatheshwara Ayurveda Hospital,Kuthpady Udupi, Karnataka, India and Old age homes in Udupi District.The primary outcomes measures will be assessed based on the changes felt by the subjects before and after the intervention and Changes in PSQI .Hence an effort has been planned through this clinical study evaluate the effect of Nadishodana pranayama and Brahmari pranayama on sleep quality in geriatric age group. |