| CTRI Number |
CTRI/2020/03/024191 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
09/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of ajmoda dhumapana an ayurvedic modality to improve lung function especially in traffic policemen who are much more exposed to air pollutants. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial Of Ajmoda Dhumapana With And Without Using Breathing Mask In Traffic Policemen of PCMC Using Peak Expiratory Flow Rate (PEFR) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sana Tahauwar Choudhary |
| Designation |
MD Final Year |
| Affiliation |
PDEA College Of Ayurved And Research Centre |
| Address |
Ayurved Rugnalaya and Multispeciality Hospital, sector no 27,Pradhikaran Akurdi,Nigdi Pune College Of Ayurved And Research Centre, Swasthavritta Department,Akurdi Sector no 25, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9689033633 |
| Fax |
|
| Email |
choudharysana3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajkumar Bobade |
| Designation |
Head of Swasthavritta Department |
| Affiliation |
Vice Principal Of PDEA College Of Ayurveda And Research Centre |
| Address |
Ayurved Rugnalaya and Multispeciality Hospital, sector no 27,Pradhikaran Akurdi,Nigdi Pune College Of Ayurved And Research Centre, Swasthavritta Department,Akurdi Sector no 25, Nigdi
College Of Ayurved And Research Centre, Swasthavritta Department,Akurdi Sector no 25, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sana Tahauwar Choudhary |
| Designation |
MD Final Year |
| Affiliation |
Post Graduate Scholar in Swathavritta subject |
| Address |
PDEA College Of Ayurved And Research Centre SECTOR NO 25 Akurdi Nigdi
PDEA College Of Ayurved And Research Centre SECTOR NO 25 Akurdi Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9689033633 |
| Fax |
|
| Email |
choudharysana3@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEA Colllege Of Ayurved And Research Centre Akurdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEA Colllege Of Ayurved And Research Centre |
| Address |
Sector No 25 Pradhikaran Nigdi Pune 411044 |
| Type of Sponsor |
Private 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 Sana Tahauwar Choudhary |
PDEA College Of Ayurved And Research Centre |
Sector no 25 Pradhikaran Nigdi Pune 411044
Pune
MAHARASHTRA |
9689033633
choudharysana3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1.Without any co morbidities.
2.Non smokers.
3.Age group 20-55 years traffic policemen irrespective of gender.
4.PEFR Zone - Green and Yellow |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of ajmoda dhumaoana |
In this study traffic polivemen will be provided with breathing mask and along with it one group will be provided with ajmoda dhumavarti such that two groups will be assessed to see add on effect of ajmoda dhumapana |
| Intervention |
Use of Ajmoda Dhumapana |
Traffic Policemen Of PCMC will be given ajmoda dhumapana to assess its effect on air pollution related respiratory ailments. One group will be provided with breathing mask and ajmoda dhumavarti and another group will be provided with only breathing mask. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Traffic policemen having air pollution related respiratory ailments.( acute or chronic bronchitis,atopic asthma,sinusitis,rhinitis,bronchospasm)
2. Non smokers
3.Age group 20-55 years.
4.PEFR -Yellow and green zone.
5.no major systemic illness. |
|
| ExclusionCriteria |
| Details |
1. Age group above 55 years.
2.Smokers.
3.Respiratory failure, chronic obstructive pulmonary disease,lung cancer,interstitial lung disease.
4.Dhumapana anarha ( raktapitta,murcha,jagaran paschat etc)
5.PEFR-Red zone |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in PEFR and air pollution related respiratory ailments after use of ajmoda dhumapana. |
Improvement in PEFR will be assessed at 15th day of trial and at end of trial (30th day of trial). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in PEFR and air pollution related respiratory ailments after use of ajmoda dhumapana. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
04/11/2020 |
| 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
Modification(s)
|
Publication not done yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
1.In this era of air pollution even healthy people experience health impacts including respiratory irritation or breathing difficulties. The risk do adverse effects depends on health status, the pollutant type, and concentration and length of exposure to polluted air. 2. It contains essential oil thymol which has antispasmodic activity on smooth muscles of trachea by acting on beta receptores of bronchus .It also has broncholytic effect and increases mucociliary action . 3. PEFR is a reliable indicator of lung function . PEFR depends on the force of contraction of expiratory muscles, elastic recoil of lungs and resistance of bronchial tree. Reduction in PEFR values may indicate the risk of obstructive airway disease in the occupational heath workers like Traffic Policemen who work in bus traffic signal areas for years together and are exposed to air pollutants everyday. 4. Therefore this study will assess effect of ajmoda dhumapana on air pollution related respiratory ailments using peak expiratory flow rate which is reliable indicator of lung function.
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