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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  
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 
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  
Status 
Not Applicable 
 
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.


 
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