Symptomatic treatment of patients suffering from productive cough associated with acute bronchitis.
- Conditions
- Health Condition 1: R05- Cough
- Registration Number
- CTRI/2022/09/045509
- Lead Sponsor
- Dr Deepali Gaikwad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Male or female 18 to 60 years and willing to give their written informed consent. 2. Patients with a recent onset of or equal to 2 days of bronchial mucus production with impaired ability to cough up, and a baseline Bronchial Severity Score (BSS) of >=5 score points out of a maximum of 20 points. 3. Patients willing to comply with the protocol requirements.
Patient with known hypersensitivity to any of the components of the formulation. 2. Patient with alcohol or drug dependence. 3. Patient with a history of clinically relevant chronic cardiovascular, kidney, gastrointestinal or liver disease. 4. Patients with antibiotic use in the preceding 2 weeks. 5. Pregnant or lactating women. 6. Female patients of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy. 7. Patients with a known history/concurrent infection including Tuberculosis (TB) requiring antibiotic treatment. 8. Patients with malignant growth or any severe somatopathic, neurologic and / or psychiatric disease. 9. Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at screening and the results are deemed clinically significant by the investigator 10. Patients who have participated in any clinical trial in the past 03 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ease of Cough and Clearance of SputumTimepoint: Week 1
- Secondary Outcome Measures
Name Time Method Adverse events reported during the studyTimepoint: Day 7;Change in mean Bronchial Severity ScoreTimepoint: Day 7;Change in Patientâ??s General WellbeingTimepoint: Day 7;Improvement in BreathlessnessTimepoint: Day 7;Serious adverse events reported during the studyTimepoint: Day 7