Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients
Recruiting · NCT06377410 · Interventional (participants receive a specific treatment) · Lead sponsor: National University of Malaysia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial. Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation. Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency .
Who can take part
Inclusion criteria
- Participants with documented post bronchodilator FEV1/FVC \< 70 or \<LLN
- Age 40 years and above
- Able to perform spirometry
- Participant with Stable COPD based on GOLD 2023 strategy
Exclusion criteria
- Diagnosis of other chronic lung diseases: Asthma, Asthma-COPD Overlap, Interstitial Lung Disease, Bronchiectasis, Lung Cancer
- Participants with contraindication for spirometry: recent cardiac complications, major surgery, severe advanced respiratory disease, or those with cognitively or neurologically impairment
- Hypersensitivity to acetylcysteine or any component of the formulation
- Hypersensitivity to dry powder ivy extract
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
- Participant on pre-existing regular mucolytics (at least 1 month prior)
- Illiterate participants
Where it is running
2 locations listed.
- National University of Malaysia, Faculty of Medicine - Cheras, Kuala Lumpur, Malaysia
- National University of Malaysia - Cheras, Kuala Lumpur, Malaysia