| CTRI Number |
CTRI/2024/11/077312 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Assess Bala Karma of Udan Vayu in the Cigarette Smokers |
|
Scientific Title of Study
|
A Cross Sectional Analytical Study to Assess Bala Karma of Udan Vayu in Cigarette Smokers With the help of Hardvard Step test |
| 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 Jayshri Vithoba Badhe |
| Designation |
PG Scholer |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
Department of Kriya Sharir PDEAs College Of Ayurved And Reserch Centre Nigdi Pune Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
08180007521 |
| Fax |
|
| Email |
jayshribadhe1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Chaudhari |
| Designation |
Assistant Professor and Guide |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
Department of Kriya Sharir PDEAs College Of Ayurved And Reserch Centre Nigdi Pune Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9975587176 |
| Fax |
|
| Email |
swati13mahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayshri Vithoba Badhe |
| Designation |
PG Scholer |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
Department of Kriya Sharir PDEAs College Of Ayurved And Reserch Centre Nigdi Pune Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
08180007521 |
| Fax |
|
| Email |
jayshribadhe1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research centre,Nigdi Pune Maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
Dr Jayshri Vithoba Badhe |
| Address |
Kriya Sharir department Ground Floor PDEAs College of Ayurveda and Research Centre Nigdi PUNE MAHARASHTRA 411044 |
| 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 Jayshri Vithoba Badhe |
PDEAs College of Ayurveda and Research Centre,Nigdi,Pune |
Kriya Sharir department,ground floor, PDEAs College Of Ayurved And Reserch Centre Nigdi,Sector no 27 Pradhikaran Pune Maharashtra 411044
Pune
MAHARASHTRA |
08180007521
jayshribadhe1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs CARC Institutional Ethical Committtee for Human Resource |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals between age group 18-40 years .Irrespective of Sex |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Smokers (min 5 cigarette a day atleast from 2 years)
non smokers of age group 18-40 years Irrespective of sex |
|
| ExclusionCriteria |
| Details |
1.Any Major illness espectially respiratory or cardio vascular disease and musculoskeletal disease
2.Occupational H/O Working in mills and factories or other places where lungs are affected by dust or fumes
3. Persons performing regular physical exercise or pranayama
4.Pregnant Women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Find Bala Karma of Udan Vayu in Cigarette Smokers with the help of Hardvard step test |
To Find Bala Karma of Udan Vayu in Cigarette Smokers with the help of Hardvard step test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare Uchwasan karma of Udan Vayu in Cigarette smokers and non smokers with the help of peak flow meter |
one time |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
05/12/2024 |
| 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)
Modification(s)
|
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
|
Cigarette smoking carries major health risk and has negative impact on body health .There is large evidence that smoking is the cause of numerous life threatening diseases. Smoking habit affect the respiratory functions of the body .So, to assess impact of smoking on Bala i.e physical strength of body,this study is selected If there are positive result this study will aware people about adverse effect of cigarette smoking , it also contributes in avoiding addiction of cigarette smoking among the people in society . |