NCT06377410Recruiting
Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients
A Randomised, Open Label, Interventional Study Evaluating the Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients (SyProNAC Trial)
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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 .
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 31 Mar 2024
- Start date
- May 2024
- Primary completion date
- Nov 2026
- Lead sponsor
- National University of Malaysia
- Diseases
- COPD
- NCT number
- NCT06377410
What you commit to
- Study type: Interventional
- Planned participants: 100
- From May 2024 to the primary completion date, Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant on pre-existing regular mucolytics (at least 1 month prior)
Other illness
- 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
Lab values
- 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
Other
- Illiterate participants
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National University of Malaysia Coordinator of this site? Confirm its status | Cheras | Malaysia | Not yet recruiting |
| National University of Malaysia, Faculty of Medicine Coordinator of this site? Confirm its status | Cheras | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.