| CTRI Number |
CTRI/2025/11/097208 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Steam Bath on Blood Glucose Control in patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Faesibility,Safety And Efficacy Of Steam Bath On Blood Glucose Levels In Patient With Type - 2 Diabetes Mellitus: A Randomized Controlled 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 A Prasanth |
| Designation |
Post Graduate Scholar - Department of Naturopathy |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Department of Naturopathy, Second floor, Postgraduate Block, Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9384990707 |
| Fax |
|
| Email |
drprasanthanbu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Arunthathi |
| Designation |
Assistant Medical Officer cum Lecturer, Department of Naturopathy |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Department of Naturopathy, Second floor, Postgraduate Block, Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9976768329 |
| Fax |
|
| Email |
star.naturo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Prasanth |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Department of Naturopathy, Second floor, Postgraduate Block, Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9384990707 |
| Fax |
|
| Email |
drprasanthanbu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital, Arignar Anna Indian Medicine Campus, Arumbakkam, Chennai -106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai - 106 |
| Type of Sponsor |
Government medical college |
|
|
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 A Prasanth |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
Government Yoga and Naturopathy Medical College and Hospital,
Department of Naturopathy, Second floor, PG block, Arumbakkam, Chennai - 106
Chennai
TAMIL NADU |
9384990707
drprasanthanbu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital, Chennai, Institutional Ethics Committee |
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 |
| Intervention |
Naturopathic intervention - steam bath |
Each subject enrolled in the study group will undergo steam bath for 20 minutes a day, 5 days a week over a two-week period. Prior to each session, Subjects will be instructed to consume a glass of water
(approximately 250 ml at room temperature) They will be instructed to sit inside a steam cabin with minimal dress that maintains an internal temperature between 142°F and 150°F. A wet compress cooled will be placed over the subject’s head. Subjects will be exposed to the steam for a duration of
20 minutes, after which they will immediately proceed to take a two-minute of cold shower In the event of any discomfort, distress, or adverse symptoms during the intervention, the steam cabin will be opened immediately to allow the subject to rest and recover. If the subject is fit and like to continue,
the procedure will be continued to complete the 20 minutes of intervention as scheduled |
| Comparator Agent |
patients will be in standard care under anti diabetic drugs |
The subjects will be in their regular anti diabetic drugs as suggested by their diabetologist. Comparator group will be on their normal routines. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with known case of T2DM
2. Subjects on regular oral anti - diabetic medications
3. Willingness to participate in study |
|
| ExclusionCriteria |
| Details |
Subjects under insulin therapy
Subjects with complications of T2DM like Neuropathy, Retinopathy etc.,
Subjects with psychiatric illness.
Women with menstruation, Pregnancy.
Subjects with other systemic disorders like renal, cardiovascular disorders,
General hydrotherapy contra-indication such as hydrophobia, hypersensitive skin, open cuts and wounds, recent surgeries and fractures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Fasting Blood Glucose Level (FBGL)
2. Post Prandial Blood Glucose levels (PPBG)
|
Fasting Blood Glucose Level (FBGL), Post Prandial Blood Glucose levels (PPBG) will be taken at baseline one day before the intervention, during assessment after 1 week of intervention, and post assessment after 2 weeks of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Feasibilty
2.Safety
3.Blood pressure & pulse rate
4.Anthropometric measures
Height, Weight
Waist-hip ratio
Body Mass Index (BMI) |
1.Feasibilty
2.Safety
3.Blood pressure & pulse rate
4.Anthropometric measures
Height, Weight,
Waist-hip ratio,
Body Mass Index will be taken at baseline, one day before the intervention, during assessment after 1 week of intervention & post assessment will be taken after 2 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
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="1"
Months="5"
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
|
A Randomized Controlled Trial design will be conducted involving 50 subjects. All the eligible subjects will be divided into 2 groups. The study group will undergo a steam bath for 20 minutes a day, 5 days in a week for 2 weeks, while the control group will undergo regular conventional management for 2 weeks. The assessments will be taken at three time points: at baseline (one day before the intervention), during assessment (after 1 week of intervention), and post (after 2 weeks of intervention). |