FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/012264 [Registered on: 28/02/2018] Trial Registered Retrospectively
Last Modified On: 23/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Effect of tobacco on the respiratory system. 
Scientific Title of Study   Assessment of nasal mucociliary clearance (NMC) using methylene blue dye amongst bidi smokers, cigarette smokers and non-smokers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Budhaditya Paul 
Designation  Post graduate student 
Affiliation  Manipal College of Dental Sciences 
Address  Department of public health dentistry, Manipal College of Dental Sciences, Madhavanagar, Udupi - 576104.

Udupi
KARNATAKA
576104
India 
Phone  9836117589  
Fax    
Email  drbudhadityapaul87@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashidhar Acharya 
Designation  Professor and Head 
Affiliation  Manipal College of Dental Sciences 
Address  Department of public health dentistry, Manipal College of Dental Sciences, Madhavanagar, Udupi - 576104.

Udupi
KARNATAKA
576104
India 
Phone  7892851667  
Fax    
Email  sh.acharya@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Budhaditya Paul 
Designation  Post graduate student 
Affiliation  Manipal College of Dental Sciences 
Address  Department of public health dentistry, Manipal College of Dental Sciences, Madhavanagar, Udupi - 576104.

Udupi
KARNATAKA
576104
India 
Phone  9836117589  
Fax    
Email  drbudhadityapaul87@gmail.com  
 
Source of Monetary or Material Support  
Department of Otorhinolarngology,Kasturba Medical College, Madhavanagar, Manipal, Udupi - 576104. 
 
Primary Sponsor  
Name  Department Of Otorhinolaryngology 
Address  Kasturba Medical College, Madhavanagar, Udupi - 576104, Karnataka. 
Type of Sponsor  Private medical college 
 
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 Budhaditya Paul   kasturba Medical College  Department of Otorhinolaryngology, 3rd Floor, Division B, room number 6,Madhavanagar, Manipal.
Udupi
KARNATAKA 
9836117589

drbudhadityapaul87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Should be either a smoker or a non-smoker male in the age group between 20 and 40 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  Individuals smoking 5 or more cigarettes/bidi per day

Males from 20 years to 40 years

 
 
ExclusionCriteria 
Details  Related systemic illness like upper and lower respiratory tract infections, symptomatic nasal pathology

Medications like decongestants, anti-histamines, saline drop, anti-cholinergics
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of Nasal mucociliary clearance amongst non-smokers, cigarette-smokers and bidi-smokers  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
None   not applicable 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2016 
Date of Study Completion (India) 07/10/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Publication not done. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: Nasal Mucociliary Clearance (NMC) system transports the mucus layer covering the nasal epithelium towards nasopharynx by ciliary beating at a frequency of 7-16 Hz. NMC is altered by septal deviations, upper respiratory infections, and drugs. Few studies have revealed significant depression of ciliary activity in smokers. We conducted this cross-sectional study to compare NMC and influence of smoking on NMC in adult non-smokers, cigarette-smokers and bidi-smokers using methylene blue dye test.

Materials and Methods: Our study included twenty non-smokers, twenty cigarette smokers and twenty bidi-smokers (20-40 years). A single drop of the methylene blue dye was placed in the anterior end of the inferior turbinate of the participants’ nasal cavity with the help of a nasal speculum.  After a period of fifteen minutes, the distance the methylene blue dye traversed inside the nasal cavity was gauged and recorded in millimetres with a nasal endoscope and a standard six-inch metal scale. NMC of the three groups were compared using Kruskal Wallis test.

Results: NMC was significantly reduced in bidi smokers (59.25 ± 12.38 mm; P < 0.05) in comparison to cigarette smokers (67 ± 5.58 mm) and non-smokers (68 ± 4.10 mm). Adjusted multivariate analysis revealed a significant association between NMC and bidi smoking; p < 0.05; 0.13(0.04-0.68), number of cigarettes/bidis smoked per day; p < 0.05; 0.33(0.07-0.99) and pack years; p < 0.05; 0.83(0.66-0.88).

Conclusions: NMC measurement is a simple and useful index for the assessment of effect of smoking on the ciliary activity of respiratory mucosa.

 
Close