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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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