| CTRI Number |
CTRI/2025/02/080900 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| 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 leg massage with lavender oil for Hypertensive patients |
|
Scientific Title of Study
|
Effect of Calf muscle massage with Lavender oil on Cardiovascular parameters in patients with Hypertension: 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 |
Dr K Sengani |
| Designation |
Post-graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor), Department of Naturopathy, Kamarajar nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
7810097405 |
| Fax |
|
| Email |
drredfruit@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department - Naturopathy (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor), Department of Naturopathy, Kamarajar nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K Sengani |
| Designation |
Post-graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor), Department of Naturopathy, Kamarajar nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
7810097405 |
| Fax |
|
| Email |
drredfruit@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamil Nadu - 603001, India |
|
|
Primary Sponsor
|
| Name |
Dr K Sengani |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor), Department of Naturopathy, 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 K Sengani |
International institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor), Department of Naturopathy, Kamarajar nagar, Chengalpattu Kancheepuram TAMIL NADU |
7810097405
drredfruit@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 Institutional Ethics Committee |
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 |
| Intervention |
Calf muscle massage with Lavender oil along with other Yoga and Naturopathy interventions |
The study group will receive a 20-minutes calf massage using lavender oil for 24 sessions. The massage will involve using a blend of 10 drops of lavender oil with 30ml of gingelly oil on the calf muscles. Each leg will be massaged for 10 minutes in a prone position during each session. |
| Comparator Agent |
Yoga and Naturopathy interventions other than Calf muscle massage with Lavender oil |
The control group will undergo naturopathic interventions other than lavender oil massage to calf muscles for 8 weeks (24 sessions). |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to participate in the study. Patients under single-drug or two-drug combination. Blood pressure range between systolic more than equal to 140 mmHg and diastolic more than and equal to 90 mmHg. Patients who were diagnosed hypertension. |
|
| ExclusionCriteria |
| Details |
Hypertension induced by kidney diseases, renal tumors. Female participants during menstruation, pregnancy and lactation. Participants with mental illness. Participants with blood pressure more than equal to 180/110 mmHg. Patients who are allergic to Aroma oil-Lavender oil |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability |
Heart Rate Variability - at baseline and after 8 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Systolic blood pressure and Diastolic blood pressure |
Systolic blood pressure and Diastolic blood pressure at baseline and after 8 weeks of interventions |
|
|
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)
|
01/03/2025 |
| 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="1" Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Hypertension is one of the
dangerous health problems which is mentioned when the systolic blood pressure
is greater than or equal to 140mmHg. According to Joint National Committee on
Prevention, Detection, Evaluation and Treatment of High blood pressure, for
adults normal is less than or equal to 120/ less than or equal to 80 mmHg, Pre
hypertension is 120-139/80-89 mmHg, Stage 1 hypertension 140-159/90-99 mmHg,
Stage 2 hypertension more than or equal to 160/ more than or equal to 100 mmHg.
An estimated 1.28 billion adults aged 30-79 years worldwide have hypertension.
Approximately 1 in 5 adults (21 percent) with hypertension. Hypertension is a
major cause of premature death worldwide. One of the global targets for
non-communicable diseases is to reduce the prevalence of hypertension 33 percent
between 2010 and 2030. The cross-sectional survey study of Indian adults shows
more than 1in 4 people had hypertension, and of these, only 1 in3 received a
diagnosis, less than 1 in 5 were treated, and only 1 in 12 had blood pressure
control. National mean values hide considerable state-level and district-level
variation in the continuum suggesting the need for targeted decentralized
solutions to improve the hypertension care continuum in India. Hypertension may
lead to cerebrovascular and cardiovascular complications. Bakhru (2000) declared
modern medical treatment of hypertension as highly unscientific because it
brings down the pressure of drugs without making any effort to remove the
underlying causes. Hypertension signifies homeostasis in coordination which
could be managed well by applying nondrug therapies with physiological
justification which is possible through naturopathy only. Rosenthal (2020) has
rightly remarked that “Doctors should first treat high blood pressure patients
with non-pharmacological methods like calorie and food restrictions, weight
control and reduction in salt intake. Every drug has some side effects. There
is no drug without side effects”. High blood pressure is existing circulation
problems that may cause heart attacks, stroke, or other disabling conditions,
when the cause of high blood pressure is removed, both the high blood pressure
and the resulting dangers may disappear. Out of 1380 papers, 52 papers up to
March 2022 were eligible for review obtained results, the most widely used
medicinal plants for Aroma therapy in patients with cardiovascular diseases are
Lavender, Damask rose, and peppermint. Most studies on the effect of
Aromatherapy in cardiovascular performance on Anxiety, sleep quality, and
Hemodynamic parameters. Today it has been proven that stress and Anxiety affect
cardiovascular regulation and subsequently negatively affect cardiovascular
parameters and tissue perfusion. In addition to cardiovascular complications,
depending on the severity and duration of exposure to stress and Anxiety, a
person may be prone to certain diseases such as sleep disorders, neurological
diseases, High blood pressure, Multiple sclerosis, and even a weakened immune
system. The active principles of lavender oil (linalool, linalyl acetate)
stimulate parasympathetic nervous system and thereby reduces stress. Dermal
application of lavender essential oil also includes the inhalational effect and
helps to reduce serum cortisol level. According to Article in Biofeedback,
December 2021 by Monica Almendras San Francisco State University that “Re
activate Your Second Heart” - Tightening and relaxing the calf muscles can
prevent the pooling of the blood. The inactivity of the calf muscles does not
allow the blood to flow upward may result in “sitting disease” contributing to
the development of diabetes and cardiovascular disease. Activating the calf
muscles as well as other leg muscles are strategies to support cardiovascular
health. So, calf massage stimulates the skeletal muscles, particularly the
gastrocnemius and soleus which play a critical role in venous return by Muscle
pump action -rhythmic compression and relaxation of calf muscles during massage
enhance the muscle pump mechanism. This action facilitates the upward flow of
blood through the veins, improving venous return to the heart and reducing the
venous pooling. Enhanced venous return increases the preload which can lead to
more efficient cardiac output. Improved cardiac output reduces the strain on
the heart and can helps to lower blood pressure. Besides increasing blood
circulation, the massage therapy strokes of effleurage, kneading and tapotement
stimulate skin receptors that send messages of relaxation to the central
nervous system. These reflexes cause vasodilation: where the blood vessels
widen to decrease blood pressure and heart rate. As such, the massage strokes
just described are known to aid hypertension – one of the most prominent
forecasters of cardiovascular disease.
Therefore, this study aims to the
effect of calf muscle massage with lavender oil on cardiovascular parameters in
patients with hypertension: a randomized controlled trial. |