| CTRI Number |
CTRI/2024/07/070267 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| 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 Cold Chest pack with Epsom salt on pulmonary function tests among Bronchial Asthma individuals |
|
Scientific Title of Study
|
Synergistic effect of cold chest pack with epsom salt on pulmonary functions among patients with bronchial asthma |
| 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 Mithun A C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Department of Natural Therapeutics.Sri Dharmasthala Manjunatheshwara College of Naturopathy and yogic sciences, ujire,Belthangady, Dakshina kannada - 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9902672179 |
| Fax |
|
| Email |
mithungowdaac7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithun A C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Department of Natural Therapeutics.Sri Dharmasthala Manjunatheshwara College of Naturopathy and yogic sciences, ujire,Belthangady, Dakshina kannada - 574240
KARNATAKA
574240
India |
| Phone |
9902672179 |
| Fax |
|
| Email |
mithungowdaac7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean Division of Nutrition and Dietetics |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Dept of Nutrition and Dietetics. Sri Dharmasthala Manjunatheshwara College of Naturopathy and yogic sciences, ujire,Belthangady, Dakshina kannada - 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
944914767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital shantivana , Dharmasthala, Dakshina Kannada , Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Mithun A C |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and yogic sciences, ujire,Belthangady, Dakshina kannada - 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 |
| Dr Mithun A C |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital |
COE , Dept of Natural theraputics, Shantivana , Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9902672179
mithungowdaac7@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: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cold chest pack |
a cotton cloth of approximately 2.5m in length and 0.5m in width will be soaked in water of 12 to 18 degree celcius tehn it will be wrung completely and then will be applied to whole thorax succeded by a wool wrap of similar width and a little grater length
Duration- 15minutes |
| Intervention |
Cold Chest Pack with epsom salt(MgSO4) |
epsom salt will be rubbed against the skin of whole thorax and with a cotton cloth of approximately 2.5m in length and 0.5m in width will be soaked in water of 12 to 18 degree celcius tehn it will be wrung completely and then will be applied to whole thorax succeded by a wool wrap of similar width and a little grater length
Duration - 15min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Bronchial asthma
subjects willing to participate |
|
| ExclusionCriteria |
| Details |
other systamic illness
anatomical deformity of chest
weak and deleberate individuals
subjects not willing to participate in the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test |
pre
post immediately after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
base line
after 1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
01/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
chest pack is one of the treatment modalities in hydrotherapy consisting of cotton cloth which is soaked in water to desired temperature and then wrung out completely which can be applied to whole thorax. the anecdotal studies sujjests that cold chest pack helps in reliving asthma . the present study is to know the combined effect of epsom salt with cold chest pack on PFT among asthma patients Informed concent will be obtained from participants explaining the study objectives , methods and intrevention . |