| CTRI Number |
CTRI/2025/03/082432 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
"Influence of ujjayi pranayama on blood pressure balance in healthy individuals." |
|
Scientific Title of Study
|
Immediate effect of ujjayi pranayama on cardioautonomic variables among young healthy volunteers a randomized cross over study |
| 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 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 |
9902980062 |
| Fax |
|
| Email |
Govindpadmanabh1234@gmail.com |
|
Details of Contact Person Scientific 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
KARNATAKA 574240 India |
| Phone |
9902980062 |
| Fax |
|
| Email |
Govindpadmanabh1234@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bindu G V |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Naturopathy and Yogic sciences, Ujire, |
| Address |
Department of Clinical Naturopathy, SDM College of Naturopathy and Yogic sciences, Ujire, near siddavana, Belthangady
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Naturopathy and Yogic sciences, Ujire, near siddavana, Belthangady, Dakshina Kannada, Karnataka, 574240 |
|
|
Primary Sponsor
|
| Name |
Dr Govindan P |
| Address |
Department of Yoga Therapeutics, SDM College of Naturopathy and Yogic sciences, Ujire, near siddavana, Belthangady, Dakshina Kannada, Karnataka, 574240 |
| 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 |
Department of yoga therapeutics ,SDM Yoga and Nature cure hospital |
Shanthivana, near Dharmasthala, Ujire, belthangady Dakshina Kannada KARNATAKA |
09902980062
Govindpadmanabh1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic Sciences, Ujire |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Relax in a sitting position |
Relax in a sitting position with open eyes, restricting movements and gestures for 10 min.
Duration : 10 minutes |
| Intervention |
Ujjayi Pranayama |
1. Sit in any comfortable meditative asana.
2. Close the eyes and relax the whole body.
3. Take the awareness to the breath in the nostrils and allow the breathing to become calm and rhythmic.
4. Feel the air passing down the windpipe, inhale and slightly contract the epiglottis ,region at the back of the throat
5. After inhalation retain the breath, closing the nostrils with right hand and lower the head to perform Jalandhara bandha.
6. Slowly release the jalandhara bandha, raise the head with hissing sound, and exhale slowly through the left nostril only.
7. Practice yogic breathing while concentrating on the sound produced by the breath in the throat. The sound of the breath should not be very loud. It should just be audible to the practitioner but not to another person unless they are sitting very close.
Duration of the practice: 8 minutes ujjayi pranayama,
at rate of 6 breaths per minute followed by natural breath awareness.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Willingness to participate in the research |
|
| ExclusionCriteria |
| Details |
1. Individuals with pre-diagnosed comorbidities.
2. Any Systemic diseases.
3. Individuals with recent surgeries, traumatic injuries, and infections.
4. Individuals with hypotension or any cardiac issues.(25)
5. Subjects with a history of alcohol and smoking.
6. Pregnancy and lactation.
7. Female subjects during menstruation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate Variability
Galvanic Skin Response
Blood Pressure
|
Baseline, During the intervention and 5 minutes after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rate pressure product
|
Baseline, During the intervention and 5 minutes after the intervention |
|
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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)
|
24/03/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
To be healthy, maintaining equilibrium between the internal and external environments is essential and the process is known as homeostasis. The body’s physiologically active systems, including the neurological, digestive, and cardiovascular systems, are all involved in maintaining homeostasis. The Autonomic Nervous System (ANS) is crucial in regulating the body’s internal environment in response to changes in the environment outside. There is growing evidence that physiological and psychological stress disrupts autonomic balance and prolonged autonomic imbalance is associated with a wide range of somatic and mental diseases. Such autonomic imbalance is reflected in measures of heart rate variability (HRV), which have been positively associated with aerobic fitness, resilience to stress, and psychological and physiological flexibility and negatively associated with cardiovascular disease, stress, neuronal atrophy, negative affective states, and maladaptive stress responses. Yoga has an impact on cardiovascular autonomic regulation. They regulate the heart rate, systolic and diastolic blood pressure and the ANS. Slow pranayama and yoga relaxation raise parasympathetic activity while lowering sympathetic activity. By balancing the sympathovagal stress response properly, these techniques improve cardiovascular health. In the traditional text, Hatha yoga Pradeepika Ujjayi pranayama is recommended for insomnia and mental tension. The simple form, without retention, is in the yogic management of heart disease. Ujjayi resistance breathing, a breathing practice taught by the yogic tradition, reduces airflow, and during expiration it increases the intrathoracic pressure due to a slight contraction of the glottis muscles, potentially resulting in intensified vagal activity. To assess the immediate effect of Ujjayi pranayama on Cardio Autonomic variables among healthy young volunteers.
|