| CTRI Number |
CTRI/2024/09/073337 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cold Sitz Bath On Obesity Among Young Adults |
|
Scientific Title of Study
|
EFFICACY OF COLD SITZ BATH ON OBESITY AMONG YOUNG ADULTS - A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ampasala Swaraj Kumar |
| Designation |
PG Scholar |
| Affiliation |
Alvas college of Naturopathy and Yogic Sciences |
| Address |
Room no-04, Department of Clinical Naturopathy, Alvas College of Naturopathy and Yogic Sciences, Mijar, Moodbidri
Room no-04, Department of Clinical Naturopathy, Alvas College of Naturopathy and Yogic Sciences, Mijar, Moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8885269825 |
| Fax |
|
| Email |
swarajkumar531@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinnetha AN |
| Designation |
Associate Professor, HOD of Naturopathy Department |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Room no-04, Department of Clinical Naturopathy,Alavs College of Naturopathy and Yogic Sciences, Mijar, Moodbidri
Room no-04, Department of Clinical Naturopathy, Alvas College of Naturopathy and Yogic Sciences
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8861064135 |
| Fax |
|
| Email |
vineethabnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijna |
| Designation |
Assistant professor |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Room no- 04, Department of Clinical naturopathy,Alvas College of
Naturopathy and Yogic Sciences, Mijar, Moodbidri
Dakshina Kannada
KARNATAKA
574225
India
Room no- 04, Department of Clinical naturopathy,Alvas College of
Naturopathy and Yogic Sciences, Mijar, Moodbidri
Dakshina Kannada
KARNATAKA
574225
India
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9060002991 |
| Fax |
|
| Email |
abjaabhijna@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 Swaraj Kumar |
| Address |
Alvas College Of Naturopathy And Yogic Sciences, Mijar, Moodbidri,
Dakshina Kannada, Karnataka, India - 574225 |
| Type of Sponsor |
Other [self sponser] |
|
|
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 Ampasala Swaraj Kumar |
Alvas Education Foundation |
Room no-04, Department of Naturopathy, Shobhavana Campus, Mijar, Moodbidre
Dakshina Kannada
KARNATAKA |
8885269825
swarajkumar531@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee 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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cold sitz bath |
cold sitz bath will be given to obesed young adults for 10 to 20 minutes for alternate days for the duration of 24 days (a total of 12 sittings) |
| Comparator Agent |
No intervention- will be asked to
follow daily routine |
Control group is not given any
intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing to participate in the study
2.Obese (Body Mass Index ≥ 30)
|
|
| ExclusionCriteria |
| Details |
1.subjects suffering from comorbidities from obesity
2.Alcohol consumption
3.Subject taking other treatment modalites
4.Narcotic drug consumption
5.Subjects with the history of any other systemic illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Body weight
2.Height
3.Waist circumference
4.Skin folds thickness
5.BMI |
1. Pre-assessment - Day 0- Before giving the
intervention.
2. Post-assessment - Day 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GRBS |
1. Pre-assessment - Day 0- Before giving the
intervention.
2. Post-assessment - Day 24 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="0"
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
|
Obesity, which is defined as an excessive build-up of adipose tissue, is currently a worldwide health epidemic.The term obesity refers to BMI above 30.Recently statistical data show the incidence of obesity is high among the young adults.Recent studies it has shown that exposure to cold water temperature reduces body fat by activating BAT(brown adipose tissue). In the recent past, quite a few studies from several laboratories showed that humans are able to increase their non-shivering thermogenesis capacity due to cold acclimation. The increase in non-shivering thermogenesis goes hand in hand with increases in brown fat presence and activity.There is evidence that stimulating adaptive thermogenesis, defined as the facultative heat produced in response to cold and diet, might serve as a means of preventing or treating obesity . A study had showed that brown-adipose-tissue activity was significantly lower in overweight, there was a significant negative relation between brown-adipose-tissue activity and BMI as well as between brown-adipose-tissue activity and percentage of body fat . A study says that Adaptive thermogenesis by means of prolonged exposure to mild cold and other ways to activate and recruit BAT have emerged as potential tools to combat obesity and its associated metabolic complications, such as insulin resistance .This study was aimed at understanding the effects of cold sitz bath on Body Mass Index, Body weight, Waist circumference, Skin fold thickness and generalized random blood sugar levels among obese individuals.
This study aims to assess the effect of cold sitz bath among young adults of both genders of age group 18 -25 years. A total sample of 70 subjects will be included after screening and randomly divided into 2 groups where the study group (n=35) will be given cold sitz bath and the control group (n=35) will be asked to follow their routine for a period of 24 days. Assessments will be recorded in the baseline (Day 0) and post-intervention (Day 24). |