| CTRI Number |
CTRI/2023/12/060813 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Investigating how the Steam Bath and Chest Pack affected the Blood Pressure, Lung Functioning and Heart Rate variability in Healthy adult females. |
|
Scientific Title of Study
|
“Examining the Effects of Steam Bath Combined with Cold Chest Packs on Heart Rate Variability, Blood Pressure, and Lung Function in Healthy Adult Females: A Parallel-Arm Open-Label 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 Kanchi Gupta |
| Designation |
MD student |
| Affiliation |
Sant Hirdarm Medical College of Naturopathy And Yogic Sciences Bairagrah Bhopal |
| Address |
Room No 22, Second Floor, Girls Hostel, Department of Naturopathy, Sant Hirdaram Medical College of Naturopathy and Yogic Sciences, bairgarh, Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7340194689 |
| Fax |
|
| Email |
kanchi96gupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavit Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Sant Hiradarm Medical College of Naturopathy And Yogic Sciences Bairagrah Bhopal |
| Address |
Room No 6 Second floor Manu Makhija Building Sant Hiradarm Medical College of Naturopathy And Yogic Sciences Bairagrah Bhopal Madya Pradesh
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7597733931 |
| Fax |
|
| Email |
shmcnys.bhavit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavit Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Sant Hiradarm Medical College of Naturopathy And Yogic Sciences Bairagrah Bhopal |
| Address |
Room No 6 Second floor Manu Makhija Building Sant Hiradarm Medical College of Naturopathy And Yogic Sciences Bairagrah Bhopal Madya Pradesh
MADHYA PRADESH
462030
India |
| Phone |
7597733931 |
| Fax |
|
| Email |
shmcnys.bhavit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sant Hirdaram Yoga and Nature cure Hospital, Sant Hirdaram Medical College of Naturopathy and Yogic Sciences Bhopal |
|
|
Primary Sponsor
|
| Name |
Dr Kanchi Gupta |
| Address |
HIG 2/2 Quzi Wajid UI Hussain Colony Nayapura Lalghati Bhopal Madhya Pradesh 462030 |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 Kanchi Gupta |
Sant Hirdaram Yoga and Nature Cure Hospital |
Sant Hirdaram Yoga and Nature Cure Hospital, Department of Naturopathy, 185-190, One Tree Hill Road, Sant Hirdaram nagar, behata, bairagarh - 462030
Bhopal
MADHYA PRADESH |
7340194689
kanchi96gupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional EthicsCommittee Sant Hiradaram Medical College Of Naturopathy And Yogic Sciences For Women |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Steam bath |
The control group will be given an intervention. They will be given steam bath. Drinking water will be given and blood pressure will be measured using mercury Sphygmomanometer. A wet towel will be placed on the head of the individuals while in steam bath. The steam bath will be given for a time of duration of 5–7 minutes. The temperature of steam will be between 110oF–115oF (43oC–46oC). After the steam bath, they will be given a small time duration to cool off the body and blood pressure will be measured again. Heart rate will be measured using ECG before and after the intervention to obtain time domain and frequency domain measures. Lung functions will be tested using Spirometer before and after the intervention. They will be given a healthy diet, including millet, veg soup, lemon honey water, and green vegetables. Total Duration - 6 months
|
| Intervention |
Steam bath and Cold chest Pack |
Experimental group will consist of 25 healthy female volunteers, age between 18-25 year, from Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal. The experimental group will be given an intervention. They will be given a steam bath combined with cold chest pack 4 times for two weeks. The cold chest pack, consists of a cotton cloth, approximately 2.5m long and 0.5m wide, soaked in water at room temperature and squeeze out completely. It will be applied over the chest, covering both front and back, followed by a wrapping of woolen flannel of the same dimensions of the cotton cloth. First, they will be put on a cold pack on chest before entering the steam bath. Drinking water will be given and blood pressure will be measured using mercury Sphygmomanometer. A wet towel will be placed on the head of the individuals while in steam bath. The steam bath will be given for a time of duration of 5–7 minutes. The temperature of steam will be between 110oF–115oF (43oC–46oC).
After the steam bath, they will be given a small time duration to cool off the body and blood pressure will be measured again. Heart rate will be measured using ECG before and after the intervention to obtain time domain and frequency domain measures. Lung functions will be tested using Spirometer before and after the intervention. They will be given a healthy diet, including millet, veg soup, lemon honey water, and green vegetables.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Healthy female individuals of age between 18 to 25 years.
Healthy female individuals without any history of systemic illness.
Body Mass Index (BMI) between 18 and 25 kg/m2
|
|
| ExclusionCriteria |
| Details |
Participants who are smokers.
Participants with a history of cardiovascular pulmonary diseases.
Participants having menstrual bleeding.
Known cases of psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood Pressure
Systolic pressure (sBP) Diastolic pressure (dBP) |
Steam bath combined with cold chest pack 4 times for two weeks, followed by 2nd month, 4th month and 6th month with same duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lung Function Test
FVC
FEV
FEF 25–75
FEF 50
Average FEF2575
PEF
Ratio FEV1/FVC
Heart Rate Variability
Time domain measures of HRV
RMSSD
SDNN
SDRR
NN50
pNN50
Frequency domain measures
ULF Power
VLF Power
LF Power
HF Power
LF/HF Ratio |
The Variable will be Measured After given steam bath 4 times for two weeks for 6 months |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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 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
|
This study aims to evaluate the impact of a combination of steam baths and cold chest packs on the health of young females aged 18 to 25 years. A total of 50 healthy female participants will be selected based on specific inclusion criteria and randomized into two groups using a computer-generated randomization tool. The allocation of participants to the experimental and control groups will be concealed using sequentially numbered, opaque, sealed envelopes (SNOSE). The experimental group will receive a combination of a steam bath and cold chest pack, while the control group will receive only a steam bath. Prior to the intervention, baseline measurements for blood pressure, lung function, and heart rate variability will be recorded. The interventions will be administered four times over a two-week period, and the study will span 12 months. The steam bath will have a duration of 5-7 minutes with a temperature ranging from 110°F to 115°F (43°C to 46°C). After the steam bath, participants will be allowed to cool off, and their blood pressure will be measured again. Heart rate will be assessed using ECG before and after the intervention to collect time domain and frequency domain data. Lung function will be evaluated using a Spirometer before and after the intervention. Due to the nature of the study, blinding of both the investigators and participants is not feasible. This research will provide valuable insights into the potential health benefits of the combined intervention of steam baths and cold chest packs on young, healthy females and could contribute to our understanding of complementary therapies for improving overall well-being. |