| CTRI Number |
CTRI/2024/05/067757 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of 20 minutes walking in foot reflexology track on blood pressure among hypertensies |
|
Scientific Title of Study
|
Effect of 20 minutes walking in foot reflexology track on blood pressure and autonomic variables among essential hypertensives |
| 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 Mithun A C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Department of Natural Therapeutics Sri Dharmasthala
Manjunatheshwara College of Naturopathy and Yogic
Sciences,ujire,Belthangady,Dakshina kannada-574240
Dakshina Kannada
KARNATAKA
574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9902672179 |
| Fax |
|
| Email |
mithungowdaac7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithun A C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Department of Natural Therapeutics Sri Dharmasthala
Manjunatheshwara College of Naturopathy and Yogic
Sciences,ujire,Belthangady,Dakshina kannada-574240
Dakshina Kannada
KARNATAKA
574240
India
KARNATAKA
574240
India |
| Phone |
9902672179 |
| Fax |
|
| Email |
mithungowdaac7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean Division of Nutrition and Dietetics |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Department of Natural Therapeutics Sri Dharmasthala
Manjunatheshwara College of Naturopathy and Yogic
Sciences,ujire,Belthangady,Dakshina kannada-574240
Dakshina Kannada
KARNATAKA
574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara yoga and Naturecure hospital Shanthivana |
|
|
Primary Sponsor
|
| Name |
Dr Mithun A C |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic
Sciences,ujire,Belthangadi,Dakshina kannada-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 Mithun A C |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana |
Center Of Excellence , Deptartment of Natural Theuraputics, shanthivana,Darmasthala,Belthangadi-574240
Dakshina Kannada
KARNATAKA |
9902672179
mithungowdaac7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic Sciences Institutional Ethics Committe |
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 |
Walkin 20 minutes in Foot Reflexology Track |
The subjects has to walk in a track which consists of pebbles with water of both hot and cold with alternate compartments, second track consists of small stones, third track consists of pebbles and fourth track consists of fine sand total duration of walking - 20minutes |
| Comparator Agent |
Walking in plain flat surface |
The Subjects has to walk in plain track with flat area
duration - 20minutes |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Aged between 35 years to 50 years
2.primary arterial hypertension
3.Under antihypertensive medication from their primary care physician or specialist at the time of the investigation.
4.Those who were willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 severe psychatric co morbidites
2 Coronary artery disease, myocardial infarction, pulmonary embolism, or stroke in the previous 3 months
3.Pregnancy or breastfeeding
4.Any pathology involving legs
|
|
|
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 |
| Blood pressure and Heart rate variability |
Baseline, during intervention and 5 min after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Galvanic skin response |
Baseline, during intervention and 5 min after intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
30/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/12/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
under review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Foot reflexology is a non-invasive
treatment and has long been practiced around the world. Traditionally foot reflexology means appliying presuure on reflex areas using hands but the prest study aims to asess by applying the pressure to reflexology area by walking in reflexology track where it consists of pebbles and different sizes of sand and stones. This is a
well-controlled, randomized trial to examine the effects of foot reflexology on
SBP, DBP, and HRV in individuals with Hypertension Day 1: Subject 1- Walking In Foot Reflexology Track 20min
Subject 2- Walking In Plain Surface 20min
Day 4: Subject 1- Walking In Plain Surface 20min
Subject 2- Walking In Foot Reflexology Track 20min
|