A Clinical Trial to compare efficacy of a polyherbal ayurvedic formulation “Dabur Honitus” versus “Standard Allopathic Formulation” for symptomatic relief of acute non productive cough and throat irritation
Completed
- Conditions
- Patients with acute non productivecough and throat irritation for less than 1week duration and age range is 18 - 65 years
- Registration Number
- CTRI/2011/05/001768
- Lead Sponsor
- Dabur India Ltd
- Brief Summary
This is a multicenter, double blind; two arm randomized, parallel group clinical study to evaluate the safety and efficacy of a polyherbal formulation Dabur Honitus versus Standard Allopathic Formulation for symptomatic relief of acute non productive cough and throat irritation. The study will be conducted across 3 centers in India. Approximately 110 subjects will be enrolled, 55 receiving the study drug and 55 receiving the reference comparator drug. Males and females between 18-65 years with acute non productive cough and throat irritation of less than 1 week duration and meeting the selection criteria will be enrolled. Screening/baseline procedures will include medical history, physical examination and vital signs. Assessment for clinical signs and symptoms, vitals and Adverse Events will be done at every follow up visit on Day 2, Day 3 and Day 4 post treatment. Response to treatment will be measured by change in frequency of cough and throat irritation from the baseline value to end of 3day treatment in both the treatment arms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
- Patients with H/O acute non productive cough and throat irritation for less than 1 week duration 2.
- Males and Females between 18-65 years age.
- Patients who in the opinion of the Investigator will be able to comply with the study requirements.
- Patients with a cough score of 0, 1 or 2 during day time 5.
- Patients willing and able to provide signed informed consent form prior to any study related procedures.
Exclusion Criteria
- Patients with H/O lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, Whooping cough.
- Patients with H/O Chronic Obstructive Pulmonary Diseases/Asthma 3.
- Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.
- Patients with known hypersensitivity to ingredients of Investigational Products 5.
- Patients with clinical suspicion of any systemic bacterial infection.
- Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment 7.
- Patients with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.
- Patients with Hypertension on Angiotensin-converting enzyme (ACE) inhibitors.
- Alcohol, smoke and drug abusers will be excluded.
- Occasional users of cigarettes and alcohol may pariticpate in the study as per the investigator’s discretion.
- Such participants should be instructed from restricting the use of cigarettes / alcohol during the study participation period.
- Patients participating in any other clinical trial.
- Pregnant or lactating females.
- Patients who have received any immunosuppressant, Sedative, Hypnotic or Tranquilizer 14 days prior to enrollment.
- Patients who have received any Anti Histaminics, Cough suppressants , Mucolytics , Expectorants or Antibiotics 3 days prior to enrollment.
- Any other condition due to which patients are deemed to be unsuitable by the Investigator for reason (s) not specifically stated in the exclusion criteria.
- Patients with H/O Parkinson’s disease who are on Mono Amine Oxidase Inhibitors (MAO) inhibitors.
- Any psychiatric illness which may impair the ability to provide written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in day and night frequencies of cough from baseline on a 6 point scale in Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days patients with acute non- productive cough receiving therapy over a period of 3 Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days 3 days Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days
- Secondary Outcome Measures
Name Time Method Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physician’s global assessment of efficacy on a 5 point scale Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physician’s global assessment of efficacy on a 5 point scale
Trial Locations
- Locations (3)
Dr. Jaideep Joshi Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Kulkarnis Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Umesh Deshpande Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Jaideep Joshi Clinic🇮🇳Mumbai, MAHARASHTRA, IndiaDr Jaideep JoshiPrincipal investigator09820775115drjaideepjoshi@hotmail.com