| CTRI Number |
CTRI/2025/12/098582 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| 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 Cool Douche to Spine on blood pressure in hypertensives. |
|
Scientific Title of Study
|
EFFECT OF COLD SPINAL DOUCHE ON AUTONOMIC VARIABLES IN INDIVIDUALS WITH ESSENTIAL HYPERTENSION-A RANDOMIZED CONTROL 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 |
Padmashree K |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Natural Therapeutics
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,Ujire,Belthangady,Dakshina Kannada,Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9741765419 |
| Fax |
|
| Email |
padmashree.krishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Padmashree K |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Natural Therapeutics
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,Ujire,Belthangady,Dakshina Kannada,Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9741765419 |
| Fax |
|
| Email |
padmashree.krishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean Division of Nutrition and Dietetics |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Nutrition and Dietetics
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,Ujire,Belthangady,Dakshina Kannada,Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara Yoga and Nature Cure Hospital, Shanthivana |
|
|
Primary Sponsor
|
| Name |
Padmashree K |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,Ujire,Belthangady,Dakshina Kannada,Karnataka-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 |
| Padmashree K |
SDM Yoga and Nature Cure Hospital |
COE, Department of Natural Therapeutics,Shantivana, Ujire Dharmasthala Road, Dharmasthala Karnataka 574216
Dakshina Kannada
KARNATAKA |
9741765419
padmashree.krishna@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 |
Cold Spinal Douche |
After positioning the subject, the intervener holds the nozzle of the apparatus at a distance of 3 to 5 meters from the subject and directs the single column of cold water temperature of 18 to 24 degree Celsius with a pressure of 40lbs towards the spine and about 1-2 inches lateral to the spine. The column of water is moved from top to bottom for 5 minutes. |
| Comparator Agent |
Cold Water Pouring |
After proper positioning, cold water at a temperature range of 18 to 24 degree Celsius will be gently poured along the spine without the use of any external pressure. The water will be allowed to flow passively from the upper back to the lower back, covering the spinal region and areas approximately 1–2 inches lateral to the spine. This procedure will be carried out continuously for a duration of 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with hypertension with or without medications.
Subjects who are diagnosed as Primary orEssential hypertension
|
|
| ExclusionCriteria |
| Details |
Weak and debilitating individuals
Hypertension with the CAD.
Hypertension with the previous stroke
Hypertension with the CKD
Hypertensive patients with ear infection, cervical spondylosis, renal or adrenal
Involvement, increased glycemic profile, current abnormal thyroid functions and psychological conditions.
Female subjects during their menstrual cycle,
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of cold spinal douche on Blood Pressure and autonomic variables. |
baseline, immediately after the intervention,30 minutes after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To quantify the changes in Heart Rate Variability (HRV), Galvanic Skin Resistance (GSR) |
baseline, immediately after the intervention,30 minutes after the intervention |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Spinal or Dorsal douche is a classical hydrotherapy technique that exerts its therapeutic effects primarily through its action on the central nervous system. Although not directly quoted, it is believed to influence blood pressure regulation and autonomic nervous system activity, as described in traditional literature. However, a thorough understanding of the physiological effects of spinal douche is essential before its integration into clinical practice. Hence, this study aims to investigate the impact of cold spinal douche on autonomic functions, to provide scientific evidence to support its mechanism of action and potential therapeutic applications. Grouping: Subjects will be divided into 2 groups 2 Groups Group 1 (55) Group 2 (55) Methods The institutional ethical clearance will be obtained prior to the conduct of the study. An informed consent will be obtained from the individuals by explaining the study objectives, methods, intervention and an informed consent will be obtained from every participant after an appraisal about the study protocol. All the rights of the individual pertaining to the study in their own language. After selecting the eligible subjects, Allotment will be done by using a Computer-generated random number Group 1: Cold spinal douche for 5 mins (55) Group 2: Cold water pouring for 5 mins (55) Assessments will be done before the intervention (T0), immediately after the intervention (T1) and 30 minutes after the intervention (T2)
|