| CTRI Number |
CTRI/2025/10/095647 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| 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 breath modification on food craving |
|
Scientific Title of Study
|
Effect of Bhramari (BHR) and Kapalabhati (KPB) practices on food cues-induced craving in obese persons. |
| 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 |
Director of Research |
| Affiliation |
Patanjali Research Foundation Trust |
| Address |
Patanjali Research Foundation Trust
Yoga Research Divison
Patanjali Yogpeeth Phase-I
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Director of Research |
| Affiliation |
Patanjali Research Foundation Trust |
| Address |
Patanjali Research Foundation Trust
Yoga Research Divison
Patanjali Yogpeeth Phase-I
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ami Gupta |
| Designation |
Assistant Scientist |
| Affiliation |
University of Patanjali |
| Address |
Patanjali Research Foundation Trust
Yoga Research Divison
Patanjali Yogpeeth Phase-I
Haridwar
Department of Yoga Science
University of Patanjali
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
ami.gupta@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Trust |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Patanjali Yogpeeth Phase I Haridwar 249405 Uttarakhand India |
| 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 (PRFT) |
Autonomic Lab
2nd Floor, Sadbhawana Building
Yoga Research and Development Divison (PRFT)
Patanjali Yogpeeth Phase I
Hardiwar 249405
Hardwar
UTTARANCHAL |
9897963254
office@prft.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Absolute control Group 4 |
Quiet seated rest (QR) |
| Comparator Agent |
Active Control Group 3 |
Breath Awareness (BAW) |
| Intervention |
The study includes two intervention sessions as BHR, KPBI whereas two control sessions including one active control as breath awareness (BAW) and a control group as Quiet seated Rest (QSR) |
Duration of the intervention/control sessions: A total duration of 53 minutes included psychological (before and after the intervention 30 minutes for assessing psychological outcomes 15 minutes each designated as pre 2, and post 1), physiological outcomes measures (23 minutes designated as Pre1, Training, D1, R, D2, Post2) and visual clue presentation included as a part of protocol.
The assessment schedule will be as follows:
TRAIT FOOD CRAVING (onetime assessment)
PRE 1: 5 minutes (HRV+RR)
PRE 2: 15 minutes (STATE IMPULSIVITY, HUNGER AND SATIETY, MOOD STATE AND STATE FOOD CRAVING (WITH FOOD PICTURE SLIDE))
Training: 2 minutes (HRV+RR)(BHR, KPB, BAW, QSR)
During: 11 minutes (HRV+RR)intervention/control session)
During 1: 5 minutes
Rest: 1 minute
During 2: 5 minutes
POST 1: 15 minutes (STATE FOOD CRAVING (WITH FOOD PICTURE SLIDE), STATE IMPULSIVITY, HUNGER AND SATIETY AND MOOD STATE)
POST2: 5 minutes (HRV+RR)
|
| Intervention |
Volitional Yoga Breathing Group 1 |
Bhramri pranayama (BHR)
|
| Intervention |
Volitional Yoga Breathing Group 2 |
Kaplabhati Pranayama |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(i) Obesity as per Asian Guidelines
(ii) willingness to participate and comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
(i) history of severe cardiovascular disease, respiratory disorders, Thyroid, diabetes, malignancy, Tinnitus, Epilepsy, Hypertension, and others including recent surgeries.
(ii) extra systole based on EKG recordings. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Psychological outcomes as a part of protocol of total duration of intervention/control session will be 53 minutes, out of which 20 minutes belongs to psychological assessments. The following psychological assessments will be carried out using standard psychological tools as detailed below
(i) Trait of obese individuals related to Food craving using Food craving Trait Questionnaire
(ii)State of obese individuals related to Food craving using Food Craving State Questionnaire
(iii)Impulsive nature of present state of obese individual using State Impulsivity Scale
(iv)Level of Hunger and Satiety in obese individuals using Hunger and Satiety scale
(v)Level of Hunger Fullness in obese individuals using Hunger Fullness Scale
(vi)Mood of obese individuals using Brief Mood Introspection Scale
(vii) Self reported quality of practice of intervention/control session using Visual Analog Scale (VAS)
|
Time points: Two Time points
1. Before the intervention
(i) Pre 1 (10 minutes): Before Pre 1 Food craving Trait Questionnaire (only one time)
(ii)Pre 2 (10 minutes): psychological assessments including Food Craving State, State Impulsivity, level of Hunger and Satiety, Hunger Fullness and
Mood using standard questionnaires used in the study.
2. After the intervention
(i)Post 2 (10 minutes): psychological assessments including, Self reported quality of practice, Food Craving State, State Impulsivity, level of Hunger and Satiety, Hunger Fullness and
Mood using standard questionnaires used in the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physiological outcomes as a part of protocol of total duration of intervention/control session will be 53 minutes, out of which 33 minutes belongs to Physiological assessments. The following Physiological assessments will be carried out using standard instrument as detailed below
Two Channel MP45 BIPOPAC polygraph for EKG (Channel 1) and respiration (channel 2)
(i) Heart Rate Variability (HRV)
(ii) Respiration Rate (RR) |
Time Points: Three Time points
1. Before the intervention
(i) Pre 1 (5 minutes): HRV and RR
(ii) Training (2 minutes): intervention/control session as a part of protocol
2. During the intervention
During (11 minutes): the duration of intervention/control session will be 11 minutes including Two epochs of during with rest as detailed below
(i) during 1 (5 minutes)
Rest (1 minute)
(ii) during 2 (5 minutes)
3. After the intervention
Post 2(5 minutes): HRV and RR
|
|
|
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)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
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 objective of the present study is to assess the efficacy of two specific volitional yoga breathing to reduce the clue induced food craving in obese individuals. In the present study the patients of both genders will be recruited from an Integrative Therapy Center located in north India. |