| CTRI Number |
CTRI/2024/07/070039 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of two drugs Benzonatate and Levodropropizine in the treatment of chronic cough in ILD patients over a period of 4 weeks |
|
Scientific Title of Study
|
An Open labelled Randomised Control Trial to compare the efficacy and safety of Benzonatate and Levodropropizine in the treatment of chronic refractory cough in ILD patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Dutt |
| Designation |
Professor and Head ,Department of Pulmonary Medicine |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 3025
Department of Pulmonary Medicine
Academic block
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996863 |
| Fax |
|
| Email |
drnaveendutt@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anmary Royson |
| Designation |
DM Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 32
OPD, ground floor B block
Department of pulmonary medicine
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9044255400 |
| Fax |
|
| Email |
anmary322@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Dutt |
| Designation |
Professor and Head ,Department of Pulmonary Medicine |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 3025
Department of Pulmonary Medicine
Academic block
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996863 |
| Fax |
|
| Email |
drnaveendutt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences,Jodhpur
Basni industrial area phase 2
Jodhpur ,Rajasthan
342005 |
|
|
Primary Sponsor
|
| Name |
Dr Naveen Dutt |
| Address |
Room no-3025
Department of pulmonary medicine
Academic building
AIIMS Jodhpur |
| Type of Sponsor |
Other [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 |
| Dr Naveen Dutt |
All India Institute of Medical sciences ,Jodhpur |
Room no 31
Ground floor ,B block
OPD building
Department of Pulmonary Medicine
Bansi industrial area phase 2 ,Jodhpur,Rajastan,342005
Jodhpur
RAJASTHAN |
8003996863
drnaveendutt@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical sciences,Jodhpur Institutional Ethics Committee(clinical trial) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Syrup Levodropropizine |
60 mg ,per oral ,thrice daily for 4 weeks |
| Intervention |
Tab Benzonatate |
100 mg ,per oral,Thrice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 year and older
2.Consenting to participate in the study
3.Radiologically or histopathologically diagnosed ILD
4.Those with chronic refractory cough
5.Patient taking same baseline treatment for ILD for last 2 weeks |
|
| ExclusionCriteria |
| Details |
1.Cognitively impaired patient
2.Pregnant or lactating female
3.Not willing to participate in study
4.Severely ill patients
5.Known hypersensitivity to local anesthetic
6.Other treatable causes of cough
7. Active smoker
8.Already taking cough medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Benzonatate and Levodropropizine in treatment of chronic refractory cough in ILD Patients using Leicester Cough Questionnaire |
2 Week and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the efficacy of Benzonatate & Levodropropizine in symptomatic relief of chronic refractory cough in ILD Patients using cough VAS score.
2. To check the safety profile of Benzonatate & Levodropropizine therapy.
3. To identify the factors affecting the outcome of therapy
|
2 week & 4 week |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 4 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| 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
|
This study is a open labelled randomised control trial to compare the efficacy and safety of benzonatate and levodropropizine in treatment of chronic refractory cough in ILD ppatients . study will be conducted in AIIMS JODHPUR .Objectives of the study are
to assess the efficacy of Benzonatate and Levodropropizine in treatment of chronic
refractory cough in ILD Patients using Leicester Cough Questionnaire ,Cough VAS
score ,To check the safety profile of Benzonatate and Levodropropizine therapy ,to identify the
factors affecting the outcome of therapy .Patient who are >18 years with
diagnosed case of ILD with Cough VAS score of
> 40mm if their giving consent ,will be included in the study
.Pregnant and lactating woman , active smokers , severly ill patients,with the
history of arrythmia and cardiac illness ,with other causes of cough ,and those
who are taking any other traditional treatment remedies will be excluded from
the study.ILD patient with chronic refractory cough attending
pulmonary medicine OPD will be enrolled in the study ,once inclusion and
exclusion criteria has fulfilled . patients will be randomised to 2 groups will
be done with a computer generated sequence . One group will receive benzonatate
capsule 100 mg TDS and the other group will get Levodropropizine syrup 10 ML TDS . we will compare
the effectiveness with the help of various cough scores like LCQ ,Cough VAS and
adverse effects will be noted.Sample size is 56 and 23 in each group .outcome will be asessed at 2 weeks and 4 weeks . |