NCT06377410 Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients
| NCT ID | NCT06377410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Malaysia |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-05-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 .
Eligibility Criteria
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
Contact & Investigator
Mohamed Faisal Abdul Hamid, MBBS (IIUM)
PRINCIPAL INVESTIGATOR
National University of Malaysia
Frequently Asked Questions
Who can join the NCT06377410 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06377410 currently recruiting?
Yes, NCT06377410 is actively recruiting participants. Contact the research team at faisal.hamid@ppukm.ukm.edu.my for enrollment information.
Where is the NCT06377410 trial being conducted?
This trial is being conducted at Cheras, Malaysia, Cheras, Malaysia.
Who is sponsoring the NCT06377410 clinical trial?
NCT06377410 is sponsored by National University of Malaysia. The principal investigator is Mohamed Faisal Abdul Hamid, MBBS (IIUM) at National University of Malaysia. The trial plans to enroll 100 participants.