Treatment of dry or productive cough
- Conditions
- Health Condition 1: J22- Unspecified acute lower respiratory infection
- Registration Number
- CTRI/2020/03/023788
- Lead Sponsor
- Virgo UAP Pharma Pvt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
1. Age 18â??50 completed years.
2. History of acute dry or productive cough <= 1-week duration.
3. Cough score of 0,1,2 as per day time cough scale.
4. Willing to give written informed consent.
5. Able to comply with study requirements.
6. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
7. Patient willing to refrain from smoking, alcohol, etc.
1. Age < 18 years.
2. Pregnant (as per urine pregnancy test) or lactating female patient.
3. Past history of drug abuse and alcohol consumption since last 6 months.
4. Symptoms of the cough for more than 1 week.
5. Known immune deficiency.
6. Lung disease (include asthma or COPD).
7. Other respiratory disorders like Tuberculosis, chronic bronchitis, asthma, suspected pneumonia, suspected bacterial infections etc.
8. History / current condition of Cardiac disease like cardiomegaly, myocardial infraction, mitral regurgitation etc.
9. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain or diarrhea.
10. Difficulty in filling in the patient diary.
11. History of uncontrolled Diabetes Mellitus.
12. Current smoker, Smoking history >10 packs per month.
13. Patient who received other medications and antibiotic (give all details) for cough within 3 days prior to Investigation drug administration.
14. History of or patients taking any medication that causes cough.
15. History of homemade therapy and patient not willing to refrain from such medications, therapy, home-made therapy during the treatment phase.
16. Patient agreed to avoid such condition like certain foods like cold foods, cold drinks, cough induced lifestyle and cold environmental conditions.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in day and night frequencies of cough: [Time <br/ ><br>frame: Baseline/Screening & 1, 2 & 3 days post-treatment] <br/ ><br>â?? Will be evaluated on 6 point scale in treated patient. 1. Change in throat irritation: [Time frame: <br/ ><br>Baseline/Screening & 1, 2 & 3 days post-treatment] â?? Will <br/ ><br>be evaluated on 6 point scale.Timepoint: 5 days
- Secondary Outcome Measures
Name Time Method 1. Duration of relief from symptoms <br/ ><br>2. Time to relief from cough and throat irritation <br/ ><br>3. Physicianâ??s global assessment of efficacyTimepoint: 5 days