| CTRI Number |
CTRI/2023/05/052696 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of a non-medical treatment for long standing cough |
|
Scientific Title of Study
|
Efficacy of a behavioural intervention for chronic refractory cough: a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Yamini Venkatraman |
| Designation |
PhD Research Scholar |
| Affiliation |
Kasturba Medical College Mangalore MAHE Manipal |
| Address |
Department of Audiology & Speech Language Pathology Kasturba Medical College Mangalore
Manipal Academy of Higher Education Manipal Dakshina Kannada KARNATAKA 575001 India |
| Phone |
08056231250 |
| Fax |
|
| Email |
yamini.kmcmlr2022@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Radish Kumar B |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Mangalore MAHE Manipal |
| Address |
Department of Audiology & Speech Language Pathology Kasturba Medical College Mangalore
Manipal Academy of Higher Education Manipal Dakshina Kannada KARNATAKA 575001 India |
| Phone |
6361212929 |
| Fax |
|
| Email |
radheesh.slp@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Radish Kumar B |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Mangalore MAHE Manipal |
| Address |
Department of Audiology & Speech Language Pathology Kasturba Medical College Mangalore
Manipal Academy of Higher Education Manipal Dakshina Kannada KARNATAKA 575001 India |
| Phone |
6361212929 |
| Fax |
|
| Email |
radheesh.slp@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Yamini Venkatraman |
| Address |
Department of Audiology & Speech Language Pathology |
| 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 |
| Yamini Venkatraman |
Kasturba Medical College, Mangalore |
Department of Audiology & Speech Language Pathology, 5th floor, KMC Hospital
Nandigudda Rd, Attavar, Mangalore, Karnataka 575001
Dr B R Ambedkar Circle, Mangalore - 575001 Dakshina Kannada KARNATAKA |
8056231250
yamini.kmcmlr2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Cough Therapy |
Behavioural intervention including patient education, breathing exercises, cough control strategies, laryngeal hydration and counselling.
Minimum of 4 sessions (weekly once) for 45 mins each and 1 two-month follow-up session. |
| Comparator Agent |
Standard Medical Care |
Standard medical care (drugs) as prescribed by physician.
Two sessions (week 1 & week 4) and 1 two-month follow-up session |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a cough complaint duration of 3-8 weeks or more, who have undergone comprehensive diagnostic evaluations and optimally treated as per the protocols but are still symptomatic/refractory to medical management for cough.
Adults who can read and speak Kannada, who are never smokers or former smokers will be included. |
|
| ExclusionCriteria |
| Details |
Patients with a history of cognitive disorders, speech-language disorders and neurodegenerative disorders will be excluded.
Diagnoses of active infections and carcinomas of the pulmonary system will also be excluded.
A cough complaint duration of less than 3 weeks will be excluded.
Patients who are on angiotensin-converting enzyme (ACE) inhibitor drugs, current smokers or everyday smokers will be excluded. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Leicester cough questionnaire (LCQ), Cough Symptom Score (CSS), Cough Visual Analogue Scale (CVAS) |
Baseline
Post-treatment
Follow-up after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acoustic analysis-Spectral amplitude measures |
Baseline
Post-treatment
Follow-up after 8 weeks |
| Voice Handicap Index (VHI) scores |
Baseline
Post-treatment
Follow-up after 8 weeks |
| Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) scores |
Baseline
Post-treatment
Follow-up after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
24/06/2023 |
| 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="2" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cough is a common
symptom of many respiratory conditions such as Chronic Obstructive Pulmonary
Disease
(COPD), upper airway cough syndrome (UACS), asthma, and reflux diseases. These conditions are optimally
assessed and treated as per standard guidelines recommended by The
American College of Chest Physicians
(CHEST) and European Respiratory Society (ERS). When the cough persists beyond 8
weeks, with an unidentified etiology, a normal chest X-ray, and is not
responding to medical treatment for the common causes, it is labelled as ‘chronic
refractory cough (CRC)’. These patients undergo multiple
clinic visits, assessment procedures, and treatment trials before being
labelled with CRC and continue to suffer from the consequences of chronic
cough. They experience a deterioration in their physical well-being and quality of life in social
contexts, work life, and leisure. The cough remains unresolved or
partially treated with medical management and thus alternative approaches are
explored. A multi-disciplinary approach to
the management of cough is advocated in the literature. Novel treatment approaches have emerged which targets the behavioural
aspects – in addition to the existing standard of care. The behavioural
interventions involved sessions focusing on four key principles: cough
education, cough suppression techniques, vocal hygiene and psycho-educational
counselling. More efficacy studies on
behavioural interventions are needed to bring awareness among physicians and
clinicians. The present study intends to investigate the effectiveness of a
behavioural intervention in the treatment of chronic refractory cough.
Hypothesis statement - The patients who receive both medical and behavioural
intervention will show improvement in terms of cough related quality of life
and cough severity scores compared to the group receiving only medical
intervention. |