| CTRI Number |
CTRI/2020/01/022640 [Registered on: 07/01/2020] Trial Registered Prospectively |
| Last Modified On: |
18/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Foot bath for Blood Pressure patients |
|
Scientific Title of Study
|
Effect Of Warm Foot Bath On Heart Rate Variability In Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Kumar |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences |
| Address |
Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences
Ujire
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8979494643 |
| Fax |
|
| Email |
abhaysinghnaturecure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha K J |
| Designation |
Dean division of natural Therapeautics |
| Affiliation |
Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences |
| Address |
Department of natural Therapeautics
Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences
Ujire
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7349424672 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha K J |
| Designation |
Dean division of natural Therapeautics |
| Affiliation |
Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences |
| Address |
Department of natural Therapeautics
Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences
Ujire
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7349424672 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhay Kumar |
| Address |
Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences |
| 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 Abhay Kumar |
Sri Dharmasthla Manjunatheshwara Yoga And Nature Cure Hospital |
Department of naturopathy
Sri Dharmasthla Manjunatheshwara Yoga And Nature Cure Hospital,
Shanthivana
Dharmasthala
Dakshina kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
8979494643
abhaysinghnaturecure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthla Manjunatheshwara College Of Naturopathy And Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Warm Foot Bath |
Warm Foot Bath for 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with essential hypertension satisfying the JNC-8 diagnostic criteria for HTN with or without anti-hypertensive medications |
|
| ExclusionCriteria |
| Details |
Secondary hypertension
Subjects diagnosed with valvular heart disease pericarditis or myocarditis evidence of heart failure with ejection fraction 35percent
acute coronary syndrome, previous Coronary artery bypass grafting, Percutaneous transluminal coronary angioplasty with or without stenting history of stroke current abnormal thyroid function; chronic renal failure, pregnancy.
Diabetes mellitus associated with hypertension
Female subjects during menstruation.
Subjects with open wounds |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
blood Presssure
Heart Rate Variablity |
15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
10/01/2020 |
| 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="5"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Patient who satisfies both Inclusion and Exclusion criteria will be taken as subjects.The temperature of the water is maintained at 40 degreee Celcious and the duration of the intervention is for 15 minutes. 13 liters of warm water are used and the lower limbs are immersed approximately for 18 cm from the sole of the foot to above completely covering the calf muscles.Pre and Post data will be taken after the intervention.
|