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CTRI Number  CTRI/2024/09/073622 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Trial To Assess How Effective Anu Tail Nasya Is In Improving The Pranvaha Srotas (Respiratory System) Of Workers Exposed To Occupational Dust, Using Spirometry As A Measurement Tool. 
Scientific Title of Study   A Clinical Study For Evaluating The Efficacy Of Anu Tail Nasya In Pranvaha Srotas Of Occupational Dust Worker By Spirometry. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGanesh Popat Dhore 
Designation  MD Scholar Kriya Sharir 
Affiliation  Dr DY Patil College Of Ayurved And Research Centre Pimpri Pune 
Address  Department of Kriya Sharir ,Dr. D.Y.Patil College Of Ayurveda And Research Centre , Sant Tukaram Nagar ,Pimpri , Pune

Pune
MAHARASHTRA
411018
India 
Phone  8652189585  
Fax    
Email  ganeshdhore615@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrKrishna Deshpande 
Designation  Assistant Professor Kriya Sharir 
Affiliation  Dr DY Patil College Of Ayurved And Research Centre Pimpri Pune 
Address  Department of Kriya Sharir ,Dr. D.Y.Patil College Of Ayurveda And Research Centre , Sant Tukaram Nagar ,Pimpri , Pune

Pune
MAHARASHTRA
411018
India 
Phone  8308840788  
Fax    
Email  vdkrishdeshpande@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrKrishna Deshpande 
Designation  Assistant Professor Kriya Sharir 
Affiliation  Dr DY Patil College Of Ayurved And Research Centre Pimpri Pune 
Address  Department of Kriya Sharir ,Dr. D.Y.Patil College Of Ayurveda And Research Centre , Sant Tukaram Nagar ,Pimpri , Pune

Pune
MAHARASHTRA
411018
India 
Phone  8308840788  
Fax    
Email  vdkrishdeshpande@gmail.com  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College of Ayurveda and Research Centre Sant tukaran nagar Pimpri Pune Maharshtra India 411018 
 
Primary Sponsor  
Name  Dr Ganesh Popat Dhore 
Address  Dr DY Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri pune 411018 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Popat Dhore  Dr DY Patil College Of Ayurved And Research Centre Pimpri Pune  Department or OPD of swasthvritta and kayachikitsa ,Dr. D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar , Pimpri , Pune
Pune
MAHARASHTRA 		 8652189585

ganeshdhore615@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Occupational Dust Worker  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga Hrudaya Sutrasthana Chapter No 20, Procedure details: Lie Straight With His Face Upwards, Extending Arms And Legs. Take Anu Tailam The Oil Is Slightly Warmed In Hot Water Bed, Just Before Administration. It Should Not Be Too Hot. It Should Just Be Lukewarm. Two Drops Of The Oil Are Instilled Into Each Nostril. After Instilling, Soles, Neck, Palms, Ears Etc. Should Be Massaged Mildly. For Next 10 Minutes, Sputum Along With Medicine May Come Out. You Have To Spit It All Out.)
(1) Medicine Name: Anu Tail, Reference: Ashtanga Hrudaya Sutrasthana Chapter No. 4/28, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Occupational Dust Exposure Of Minimum 1 Year
2.Painter Carpenter
3.Stone Breaker
4.Sweeper
5.Construction Worker  
 
ExclusionCriteria 
Details  1.Known Case Of Copd
2.Asthma
3.Hypertension
4.Cancer
5.Diabetes Mellitus
6.Pregnant Woman
7.Tobacco Consumers
8.Ischemic Heart Disease
9.Covid-19 History
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Any Changes In Spirometry Reading In Individual Treated With Anu Tail Nasya  0 day,10 day,21 days 
 
Secondary Outcome  
Outcome  TimePoints 
any cahnge in spirometry after use of Anu Tail Nasya  0th day 10th day 21th day 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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 2/ Phase 3 
Date of First Enrollment (India)   19/09/2024 
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="6"
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   Volunteers are selected who has minimum 1 year dust exposure  of age 21 to 50 years of both genders .dust exposures like painter and carpainter and stone breaker and sweeper and construction workers will be selected . firstly results of spirometry in selected volunteers are recorded. training regarding nasya procedure will be given to volunteers. then anu tail nasya is given to volunteers for next 21 days . procedure should be done by volunteers themselves. spirometry is repeated after after 21 days and result are reecorded. statitical test will be  applied on the result and conclusion will be made. 
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