| CTRI Number |
CTRI/2025/01/079559 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| 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
|
Ujjayi pranayama on heart rate variability in Hypertension |
|
Scientific Title of Study
|
Evaluating the Effect of Ujjayi pranayama on heart rate variability in Hypertension-A Randomised 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 |
Dr Pavithra S |
| Designation |
Post-Graduate Scholar |
| Affiliation |
International institute of yoga and naturopathy medical sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9789145024 |
| Fax |
|
| Email |
drpavithrasanthanam99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gayathri A |
| Designation |
Head of Department (Yoga) |
| Affiliation |
International institute of yoga and naturopathy medical sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu chengalpattu Kancheepuram TAMIL NADU 603001 India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pavithra S |
| Designation |
Post-Graduate Scholar |
| Affiliation |
International institute of yoga and naturopathy medical sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu chengalpattu Kancheepuram TAMIL NADU 603001 India |
| Phone |
9789145024 |
| Fax |
|
| Email |
drpavithrasanthanam99@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Science,Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr Pavithra S |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu |
| 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 Pavithra S |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu. |
184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu Kancheepuram TAMIL NADU |
9789145024
drpavithrasanthanam99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
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 posture |
Control group will be asked to rest in sitting for
10 minutes a day for the period of fourteen days along with regular intake of medication. |
| Intervention |
Ujjayi pranayama |
The study participants will receive one day of orientation before the trial. The study
participants will be asked to sit in sukhasana, Keep the eyes closed throughout the practice.
Inhale slowly and deeply through the nose,take the awareness to the breath.Aftersome
time,transfer the awareness to the throat.Feel or imagine that the breath is being drawn in and
out through the throat and not through the nostril, as if it is taking place through a small hole
in the throat.As the breathing becomes slower and deeper, gently contract the glottis so that a
soft snoring sound, like the breathing of a sleeping baby(26).Continue to practice in the same
way, performing 8 rounds/minute for 3 minutes followed by 30 seconds of normal breathing.
Study participants will receive ten minutes of intervention per day for the period of fourteen
days along with their regular intake of medication. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients under a single drug or two drug combination.
Moderate hypertensive (systolic 140–179 mmHg) and (diastolic 90–109 mmHg)
(2017 American Heart Association (AHA)guidelines)
|
|
| ExclusionCriteria |
| Details |
1. Patients with secondary hypertension
2. Diabetes mellitus, coronary artery dis-ease, heart failure, arrhythmia, rheumatic heart
disease, congenital heart disease, and other significant systemic (renal, hepatic,
pulmonary, neurological and psychiatric) diseases or complications.
3. Those who are practicing yoga regularly for more than one or three months.
4. Women during pregnancy and menstruation.
5. Hypertensive patients with Blood Pressure beyond Moderate hypertension (2017
AHA guidelines) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability |
Before and after completing the intervention for a period of 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| blood pressure |
Before and after completing the intervention for a period of 14 days |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="1" Days="1" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Hypertension (HTN) is defined by a systolic blood pressure (SBP) of 130 mm Hg or higher and/or a diastolic blood pressure (DBP) of 80 mm Hg or higher. It is one of the most prevalent chronic conditions and a leading cause of stroke, heart disease, heart failure, and kidney failure. In India, hypertension is responsible for a significant percentage of fatalities. One reason for this is a lack of awareness, as many individuals remain asymptomatic until major health issues arise. Around 90-95% of hypertension cases are primary (essential), caused by environmental, genetic, and lifestyle factors such as poor diet, smoking, alcohol, and sedentary habits. Age-related metabolic disorders like insulin resistance also contribute to higher blood pressure, which increases the risk of various cardiovascular and kidney diseases. Management of hypertension involves lifestyle changes like diet and exercise. If ineffective, medication such as diuretics, beta-blockers, calcium channel blockers, ACE inhibitors, and ARBs may be prescribed to achieve a target blood pressure of 130/80 mm Hg or lower. Yoga, especially pranayama (breathing exercises), has been found to have a significant antihypertensive effect. Pranayama involves controlled breathing techniques like inhalation, retention, and exhalation to regulate heart rate and blood pressure. It reduces heart rate and both systolic and diastolic blood pressure, benefiting the cardiovascular system. Ujjayi pranayama, known as "victorious breath," is particularly beneficial for reducing stress and improving cardiovascular function. This technique helps restore autonomic balance by reducing sympathetic nervous activity and enhancing parasympathetic response, which improves heart rate and overall heart health. Heart rate variability (HRV) is a useful tool to assess autonomic nervous system function, and studies show that pranayama can increase HRV, improving the balance between the sympathetic and parasympathetic systems. This balance is essential for managing stress and hypertension effectively. Overall, yoga and pranayama provide a complementary approach to hypertension management by promoting relaxation, improving autonomic function, and reducing stress. These practices offer an additional, natural option for those seeking non-pharmacological ways to manage their blood pressure. |