| CTRI Number |
CTRI/2026/02/102723 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| 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
|
immediate response of ujjayi pranayama on blood pressure and heart rate variability hypertension induviduals |
|
Scientific Title of Study
|
Immediate autonomic and hemodynamic responses to ujjayi pranayama in adults with hypertension : A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Govindan P |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic sciences, Ujire, |
| Address |
Department of yoga Therapeutics, SDM College of Naturopathy and Yogic sciences, Ujire, near siddavana, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
09902980062 |
| Fax |
|
| Email |
Govindpadmanabh1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BINDU |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
SDM College of Naturopathy and Yogic sciences, Ujire, |
| Address |
Department of yoga Therapeutics, SDM College of Naturopathy and Yogic sciences, Ujire, near siddavana, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Govindan P |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic sciences, Ujire, |
| Address |
Department of yoga Therapeutics, SDM College of Naturopathy and Yogic sciences, Ujire, near siddavana, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
09902980062 |
| Fax |
|
| Email |
Govindpadmanabh1234@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Govindan P |
| Address |
Hakkipikki colony, near wonderla gate , bidadi hobli,ramanagara taluk and district
562109 |
| 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 Govindan P |
SDM Yoga and Nature cure hospital |
Department of yoga Therapeutics, SDM College of Naturopathy and Yogic sciences, Ujire, near siddavana, Belthangady
Dakshina Kannada
KARNATAKA |
09902980062
Govindpadmanabh1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
sitting in meditative posture |
sitting in any comfortable meditative posture with open eyes
5 minutes |
| Intervention |
UJJAYI PRANAYAMA |
PROCEDURE:
Sit in any comfortable meditative asana.
Close the eyes and relax the whole body.
Take the awareness to the breath in the nostrils and allow the breathing to become calm
and rhythmic.
Feel the air passing down the windpipe, inhale and slightly contract the epiglottis,region
at the back of the throat
After inhalation retain the breath, closing the nostrils with right hand and lower the head
to perform Jalandhara bandha.
Slowly release the jalandhara bandha, raise the head with hissing sound, and exhale
slowly through the left nostril only.
inhalation -10 seconds
breath hold in jaladhra banda 15sec
exhalation 10 sec
total duration of pranayama: 5 minutes
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 30 to 65 years, of either sex.
Clinically diagnosed primary (essential) hypertension, defined as:
Systolic Blood Pressure more than 140 mmHg and or
Diastolic Blood Pressure more than 90 mmHg,
measured on at least two occasions,
or individuals receiving stable antihypertensive medication for at least 4 weeks.
Resting blood pressure at screening less than or equal to 180/110 mmHg.
Individuals willing and able to participate in the study and comply with study procedures, including sitting quietly and performing guided breathing for 15 minutes.
Participants not practicing yoga, pranayama, meditation, or any structured breathing techniques regularly in the preceding 3 months.
Stable clinical condition without any acute illness at the time of enrollment.
Ability to understand the study procedures and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Secondary hypertension, including renal, endocrine, or drug-induced causes.
Severe or uncontrolled hypertension, defined as:
Systolic BP more than 180 mmHg and or
Diastolic more than BP 110 mmHg.
History or evidence of major cardiovascular disease, including:
Coronary artery disease or previous myocardial infarction
Heart failure
Significant valvular heart disease
Clinically significant cardiac arrhythmias
Diabetes mellitus with autonomic neuropathy or poorly controlled diabetes HbA1c more than 8.5 percent.
Known autonomic nervous system disorders or neurological conditions affecting autonomic regulation.
Chronic respiratory disorders that may interfere with breathing practices, such as:
Bronchial asthma requiring regular medication
Chronic obstructive pulmonary disease (COPD)
Chronic kidney disease (Stage 3 or above), chronic liver disease, or any other severe systemic illness.
Current use of medications known to markedly affect autonomic function or HRV, including:
Anti-arrhythmic drugs
Tricyclic antidepressants or other centrally acting psychotropic drugs
(Participants on antihypertensive drugs with stable dosage were not excluded.)
Regular practice of yoga, pranayama, meditation, or breath-control techniques within the preceding 3 months.
Inability to perform Ujjayi Pranayama due to:
Severe nasal obstruction
Recent nasal or throat surgery
Severe anxiety or panic disorder precipitated by breath regulation
Consumption of caffeine, nicotine, or alcohol within 12 hours prior to assessment.
Pregnant or lactating women.
Presence of any acute illness, infection, or fever within the preceding 7 days.
Participation in another interventional clinical trial within the last 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability
Blood pressure
Heart rate |
before the ujjayi pranayama 5 minutes
during ujjayi pranayama 5 minutes
after the ujjayi pranyama 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
mean arterial pressure
rate pressure product |
before the ujjayi pranayama 5 minutes
during ujjayi pranayama 5 minutes
after the ujjayi pranyama 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2026 |
| Date of Study Completion (India) |
25/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Hypertension is a major risk factor for cardiovascular morbidity and mortality and is associated with autonomic nervous system imbalance characterized by sympathetic overactivity and reduced parasympathetic tone. Yogic breathing techniques such as Ujjayi pranayama have been shown to influence autonomic regulation and cardiovascular function. This study is a randomized parallel group active controlled trial designed to evaluate the immediate effects of Ujjayi pranayama on cardiovascular and autonomic parameters in individuals with primary hypertension. Ninety eligible participants will be randomly allocated to either an intervention group practicing Ujjayi pranayama or a control group undergoing quiet sitting with spontaneous breathing. Cardiovascular and autonomic parameters including blood pressure, heart rate, mean arterial pressure, rate pressure product, and heart rate variability will be assessed during three time periods: five minutes before the intervention, five minutes during the intervention, and five minutes after the intervention. The study aims to assess the immediate autonomic and cardiovascular responses to Ujjayi pranayama and to explore its potential role as a non pharmacological adjunct in the management of hypertension |