| CTRI Number |
CTRI/2024/06/069239 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of cold spinal douche and neutral spinal douche in Healthy individuals |
|
Scientific Title of Study
|
Immediate Effect of Cold Spinal Douche and Neutral Spinal Douche on Autonomic Variables in Healthy Individuals- A Counter Balanced Randomized Crossover 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 Kotresh Hiremath R |
| Designation |
PG Student |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Natural therapeutics,
SDM College of Naturopathy and Yogic Sciences,Ujire,Belthangady,
Dakshina Kannada-574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277466588 |
| Fax |
|
| Email |
kotreshhm97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kotresh Hiremath R |
| Designation |
PG Student |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Natural therapeutics,
SDM College of Naturopathy and Yogic Sciences,Ujire,Belthangady,
Dakshina Kannada-574240
Karnataka
India
KARNATAKA
574240
India |
| Phone |
8277466588 |
| Fax |
|
| Email |
kotreshhm97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Professor and Dean Division of Nutrition and Dietetics Department |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Nutrition and Dietetics,
SDM College Of Naturopathy and Yogic Sciences,Ujire,Belthangady,
Dakshina Kannada-574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shativana, Dharmasthala,
Belthangady, Dakshina Kannada
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Dr Kotresh Hiremath R |
| Address |
Department of Natural Therapeutics,
SDM College Of Naturopathy and Yogic Sciences, Ujire, Belthangady,
Dakshina Kannada-574240
Karnataka
India |
| 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 Kotresh Hiremath R |
Shri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital Shanthivana |
COE, Department of Natural Therapeutics,
Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital Shantivana, Dharmasthala, Belthangady,
Dakshina Kannada-574216
Karnataka,
India
Dakshina Kannada
KARNATAKA |
8277466588
kotreshhm97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cold spinal douche |
After positioning the subject, the intervener stands holding the nozzle of the apparatus at a distance of 3.5 meters away from the subject and directs the single column of cold water of
temperature 18 to 24℃ with pressure of 40lbs towards the spine and about 1-2 inches
lateral to the spine moving the column of water from top to bottom for
Duration- 5 minutes. |
| Comparator Agent |
Neutral Spinal Douche |
After positioning the subject, the intervener stands holding the nozzle of the apparatus at a distance of 3.5 meters away from the subject and Neutral douche at a temperature of 33 to 36°C and pressure of 40lbs was administered towards the spine and about 1-2 inches lateral to the spine moving the column of water from top to bottom for a
Duration-5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Age: 18 – 30 years
2 Subjects who are willing to participate in the study
3 Gender: Male and Female
|
|
| ExclusionCriteria |
| Details |
1 Weak and debilitating individuals
2 Systemic illness
3 Subjects with open wounds
|
|
|
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 |
| Heart Rate Variability(HRV) |
Baseline and 5 minutes post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Heart Rate
2 Blood Pressure |
1 Baseline & 5 minutes post intervention
2 Baseline & 5 minutes post 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 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
15/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/08/2025 |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Spinal douche is a treatment modality used in hydrotherapy. Traditional references
suggests the beneficial effect of spinal douche may control the blood pressure and autonomic
functions. It is necessary to understand the physiological effect of the treatment before
being used as a treatment modality. Hence this study is designed to understand the effect cold
and neutral spinal douche on autonomic function. Objectives of the study To assess the effect of cold and neutral spinal douche on Heart Rate (HR), Blood
Pressure (BP). To quantify the changes in Heart Rate Variability (HRV). Allotment will be done by using a Computer generated random number Day 1: Subject 1- Cold spinal douche for 5 minutes Subject 2- Neutral spinal douche for 5 minutes Day 4: Subject 1- Neutral spinal douche for 5 minutes Subject 2- Cold spinal douche for 5 minutes Assessments will be done before the intervention and immediately after the intervention |