| CTRI Number |
CTRI/2020/03/024127 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
16/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study of respiration in persons exposed to air pollution with the help of parameter breath holding time |
|
Scientific Title of Study
|
Observational study of shawasan prakriya (respiration) in air pollution exposed individuals on parameter breath holding time |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jai Chandrashekhar Suryavanshi |
| Designation |
MD Scholor |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
| Address |
Department of Kriya sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28
Department of Kriya sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
9922972933 |
| Fax |
|
| Email |
jai17surya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRANITA JOSHI DESHMUKH |
| Designation |
READER |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
| Address |
Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28
Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
9822229579 |
| Fax |
|
| Email |
pranitaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jai Chandrashekhar Suryavanshi |
| Designation |
M D scholor |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
| Address |
Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28
Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
9922972933 |
| Fax |
|
| Email |
jai17surya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
|
|
Primary Sponsor
|
| Name |
Jai Chandrashekhar Suryavanshi |
| Address |
Department of kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
| Type of Sponsor |
Other [PRINCIPLE INVESTIGATOR (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 |
| Jai Chandrashekhar Suryavanshi |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
Department of Kayachikitsa (Out patient Department no 1 and out patient Department no 2 In patient Department NO 2)
Pune
MAHARASHTRA |
9922972933
jai17surya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMS Sumatibhai shah Ayurved Mahavidyalaya and Sane Guruji Arogya kendra Malwadi, Hadapsar. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Air pollution exposed individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.who are willing to participate in study
2.who are available at the time of data collection
3.Selected as per the screening test having moderate to severe score.
4. Apparently healthy individuals
5. minimum continuously exposed to air pollution for 3 years in polluted urban area considering air quality index range 51-150 |
|
| ExclusionCriteria |
| Details |
1.Having systemic diseases like asthma, COPD etc
2.Addiction smoking, alcoholic |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Air pollution affects the shawasan prakriya (respiration) in pollution exposed individuals. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To validate the screening test and to assess shawasana prakriya (respiration) with the help breath holding time along with additional tests for air pollution exposed individuals. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study to assess the effect of air pollution exposure to the individuals and their Shawasan prakriya (respiration) on parameter breath holding time. Harmful contents of the air pollutants may affect the potency of shwasan prakriya(Respiration).Automobile fuel combustion is the primary source of a large number of health damaging air pollutants. By the assessment of Shwasan prakriya (respiration) in pollution exposed individuals the risk of incidence of respiratory disease can be identified.
Individuals directly exposing minimum 3-5 hours of exposure for 5 days per week for 5 years in the urban area will be selected for the study. Breath holding time can prove economically feasible,measurable objective and requires no machineries or expertise and may give idea about the lung functioning improve diagnostic approach. Breath holding time along with other test will be used as an evaluator of cardio-pulmonary reserve.
|