Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT06377410
- Lead Sponsor
- National University of Malaysia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - Participants with documented post bronchodilator FEV1/FVC < 70 or <LLN<br><br> - Age 40 years and above<br><br> - Able to perform spirometry<br><br> - Participant with Stable COPD based on GOLD 2023 strategy<br><br>Exclusion Criteria:<br><br> - Diagnosis of other chronic lung diseases: Asthma, Asthma-COPD Overlap, Interstitial<br> Lung Disease, Bronchiectasis, Lung Cancer<br><br> - Participants with contraindication for spirometry: recent cardiac complications,<br> major surgery, severe advanced respiratory disease, or those with cognitively or<br> neurologically impairment<br><br> - Hypersensitivity to acetylcysteine or any component of the formulation<br><br> - Hypersensitivity to dry powder ivy extract<br><br> - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a<br> female after conception and until the termination of gestation, confirmed by a<br> positive hCG (human Chorionic Gonadotropin) laboratory test<br><br> - Participant on pre-existing regular mucolytics (at least 1 month prior)<br><br> - Illiterate participants
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.
- Secondary Outcome Measures
Name Time Method to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life.;to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry;to determine change of Forced Vital Capacity in litres/minute using spirometry;to determine adverse effects of Syrup Prospan (in %);to determine adverse effects of N-Acetylcysteine (in %);To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied)