| CTRI Number |
CTRI/2025/04/084893 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Quick Cooling Power of Cold Water Enemas for Fever in Adults |
|
Scientific Title of Study
|
IMMEDIATE EFFECT OF COLD WATER ENEMA ON FEVER AMONG ADULTS: A SINGLE ARM STUDY |
| Trial Acronym |
ENEMA-S |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShradha M K |
| Designation |
PG SCHOLAR |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Room no- 04, Department of Clinical Naturaopathy ,Alvas College of
Naturopathy and Yogic Sciences, Mijar, Moodbidri
Dakshina Kannada
KARNATAKA
574225
India
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9591937218 |
| Fax |
|
| Email |
shradhamooleena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr lakshmeesha D R |
| Designation |
Associate Professor |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Room no- 04, Department of Clinical Naturaopathy ,Alvas College of
Naturopathy and Yogic Sciences, Mijar, Moodbidri
Dakshina Kannada
KARNATAKA
574225
India
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9741735734 |
| Fax |
|
| Email |
dr.lakshmeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saritha N K |
| Designation |
Assistant professor |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Room no- 04, Department of Clinical Naturaopathy ,Alvas College of
Naturopathy and Yogic Sciences, Mijar, Moodbidri
Dakshina Kannada
KARNATAKA
574225
India
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
7088552712 |
| Fax |
|
| Email |
sarithahegde2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College Of Naturopathy And Yogic Sciences, Mijar ,Moodbidri ,Dakshina Kannada, Karnataka, India 574225 |
|
|
Primary Sponsor
|
| Name |
Dr. Shradha M K |
| Address |
Alvas College Of Naturopathy And Yogic Sciences, Mijar ,Moodbidri ,Dakshina Kannada, Karnataka, India 574225 |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 Shradha M K |
Alvas Education Foundation |
Room no- 04, Department of Clinical Naturaopathy ,Alvas College of
Naturopathy and Yogic Sciences, Mijar, Moodbidri
Dakshina Kannada
KARNATAKA
574225
India
Dakshina Kannada
KARNATAKA |
9591937218
shradhamooleena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee for Human Studies of Alvas College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrotherapy- cold water enema |
Cold water enema at the temperature of 80 degree fahrenheit around 1 to 1.5 liters is given to the fever patients and retain the water for 5-10 minutes and then will allow to go to toilet where he/she instructed to expel the water slowly along with accumulated stools |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with fever 3days or less than 3 days
2. Temperature of 38°C [100.4°F] or more
3. Age group of “18-30" yrs
4. Gender both males and females
5. Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Females with menstrual cycle
2. Fistula
3. Anal fissure
4. Hemorrhoids
5. Diarrhea
6. Pregnancy
7. Fever with chills
8. Any Medication if they are taking |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Temperature |
Assessments done at two time points
1. Pre assessment- Before intervention
2. Post assessment - After intervention - 5mins, 15mins, 30mins, 45mins, 1st hour, 3rd hour, 6th hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pulse rate
2. Respiratory rate
3. Systolic BP
4. Diastolic BP |
Assessments done at two time points
1. Pre assessment- Before intervention
2. Post assessment - After intervention - 5mins, 15mins, 30mins, 45mins, 1st hour, 3rd hour, 6th hour. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 1 |
|
Date of First Enrollment (India)
|
27/04/2025 |
| 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="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The term ’Fever’ implies to elevated core body temperature of 38-degree Celsius or more in disease or illness. Elevated temperature is a common symptom of many diseases; it can be caused by various factors including infections [ bacteria or virus] and no infectious causes [inflammatory conditions, heat stroke, or medicine side effects]. According to Naturopathy, Fever is considered as fermentation going in the body, foreign matter enters the body and gets settled in areas of favorable environment due to the state of lowered vitality. Fever produces a retrogressive metamorphosis and creates an environment to decomposes this foreign matter and expel it. Enema includes ’cleaning out’ the lower portion of the intestine using water which helps in detoxifying the fermented morbid matter. There are several antipyretics used to decrease fever, but it has its own side effects. There is no previous study on Immediate effect of cold-water enema for fever among adults therefore the present study aims to understand the Immediate effect of cold-water enema among adults, a single arm study. This study aims to assess the Immediate effect of cold enema on Fever among the adults on both genders of age group 18-30 years with the temperature of 38 degree Celsius or more. Total sample of 45 subjects will be given one session of cold enema. Assessment will be recorded before the treatment and post assessment will be recorded after the treatment, 5min, 15min, 30min, 45min, 1st hour, 3rd hour and 6th hour |