Clinical study on WKF Syrup (Cough Syrup) in Cough
- Conditions
- Health Condition 1: R05- Cough
- Registration Number
- CTRI/2022/04/042046
- Lead Sponsor
- Welex laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Subject suffering from uncomplicated cough that does not require antibiotic treatment
2.The onset time should not be more than 3 days
3.Willing to sign informed consent.
1.Cough caused by bronchial asthma, tuberculosis, bronchiectasis, and other diseases that have been clearly diagnosed as chronic obstructive pulmonary disease and/or severe respiratory tract infection.
2.Patient with known current lung cancer and fibrosis of lung
3.Patients with uncontrolled diabetes or hypertension;
4.Subjects with known current serious illness, e.g., multisystem failure, chronic liver disease, HIV, cancer, renal failure, serious cardiovascular disease.
5.Women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial
6.Known allergy to any ingredient of study products
7.Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Comparative assessment of number of days required and number of subjects completely recovered from cough over a period of 14 days between the two groups <br/ ><br>2.Comparative change in day and night frequencies of cough on a graded scale based on subject diary from baseline to end of therapy and between the two groups. <br/ ><br>Timepoint: Screening Visit (up to day 3), Baseline Visit (Day 0), Visit 1 Telephonic follow up (Day 4), Visit 2 (Day 7), Visit 3 Telephonic follow up (Day 10), Visit 4 (Day 14 or Complete resolution of Cough)
- Secondary Outcome Measures
Name Time Method 1.Comparative change in throat irritation on graded scale based on subject diary <br/ ><br>2.Comparative change in sputum production on graded scale based on subject diary <br/ ><br>3.Comparative assessment of requirement of rescue medications based on subject diary <br/ ><br>4.Global assessment for overall change assessed by physician and subjects at the end of the study <br/ ><br>5.Assessment of tolerability of study products by evaluating ADRs <br/ ><br>Timepoint: Screening Visit (up to day 3), Baseline Visit (Day 0), Visit 1 Telephonic follow up (Day 4), Visit 2 (Day 7), Visit 3 Telephonic follow up (Day 10), Visit 4 (Day 14 or Complete resolution of Cough)