| 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
|
|
|
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
|
|
|
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. |