| CTRI Number |
CTRI/2026/01/100732 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring the Effects of Nadishodhan and Bhramari Pranayama on Electroencephalogram,Heart rate variability,P300,Pulmonary function test in Dementia: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Neurophysiological Respiratory Effects of Nadishodhan (Alternate Nostril Breathing) and Bhramari (Humming Bee Breath)Pranayama in Dementia: A Randomized Controlled 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 |
JAYANTI MISHRA |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
DEPT OF PHYSIOLOGY
AIIMS BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
7809093730 |
| Fax |
|
| Email |
physio_jayanti@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
ANIRVAN BHATTACHARYA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
DEPT OF PHYSIOLOGY
AIIMS BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
9330758473 |
| Fax |
|
| Email |
anirvan1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JAYANTI MISHRA |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
DEPT OF PHYSIOLOGY
AIIMS BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
7809093730 |
| Fax |
|
| Email |
physio_jayanti@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JAYANTI MISHRA |
| Address |
DEPT OF PHYSIOLOGY
AIIMS BHUBANESWAR
BHUBANESWAR-751019
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DRJAYANTI MISHRA |
AIIMS BHUBANESWAR |
DEPT OF PHYSIOLOGY
AIIMS BHUBANESWAR
Khordha
ORISSA |
07809093730
physio_jayanti@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere, (2) ICD-10 Condition: F039||Unspecified dementia, (3) ICD-10 Condition: F015||Vascular dementia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nadishodhan & Bhramari PRANAYAMA + TREATMENT AS USUAL |
ALTERNATE NOSTRIL BREATHING & HUMMING BEE BREATH FOR 5 DAYS A WEEK FOR 12 WEEKS + TREATMENT AS USUAL |
| Comparator Agent |
TREATMENT AS USUAL |
DRUGS PRESCRIBED BY NEUROLOGIST |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjective complaints in decline in memory
Diagnosed cases of dementia (MMSE score less than 24) According to DSM V |
|
| ExclusionCriteria |
| Details |
No use of cognitive enhancers which modulate EEG markers at least 6weeks prior to the
test
H/o Hearing and visual loss
H/o substance abuse disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in EEG Parameters,HRV,P300,PFT Parameters |
Baseline and at the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlations Between Biomarkers |
Baseline & at the end of 12weeks |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
20/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a prospective, parallel-group, randomized controlled trial conducted in patients diagnosed with dementia. Eligible participants are randomly allocated into an intervention group and a control group. The intervention group receives structured training in Nadishodhan and Bhramari pranayama in addition to standard treatment, while the control group receives standard treatment alone. The pranayama intervention is administered under supervision for a predefined duration. Neurophysiological and autonomic assessments are performed at baseline and after completion of the intervention. Outcome measures include electroencephalographic (EEG) analysis of cortical activity, heart rate variability (HRV) for autonomic balance, PFT -derived parameters (PFT) for RESPIRATORY and autonomic function, and P300 event-related potentials to assess attention and cognitive processing speed |