Comparing the effects of Ivy Extract and NAC in 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)
NA · National University of Malaysia · NCT06377410
This study is testing whether Ivy Extract works better than N-acetylcysteine for helping people with COPD feel better and improve their lung function over 30 days.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | National University of Malaysia (other) |
| Locations | 2 sites (Cheras, Kuala Lumpur and 1 other locations) |
| Trial ID | NCT06377410 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of dry powder Ivy Extract (Syrup Prospan) compared to N-acetylcysteine (NAC) in patients with Chronic Obstructive Pulmonary Disease (COPD). It is a randomized, open-label interventional study where participants will be assigned to receive either Syrup Prospan or NAC for 30 days. The study will assess cough symptoms, health-related quality of life, and lung function before and after treatment. Participants will also provide feedback on their satisfaction with the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and above with stable COPD and documented lung function impairment.
Not a fit: Patients with other chronic lung diseases or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative treatment for managing COPD exacerbations.
How similar studies have performed: Previous studies have shown positive outcomes with mucolytic treatments in COPD, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cheras, Kuala Lumpur and 1 other locations
- National University of Malaysia, Faculty of Medicine — Cheras, Kuala Lumpur, Malaysia (RECRUITING)
- National University of Malaysia — Cheras, Kuala Lumpur, Malaysia (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Mohamed Faisal Abdul Hamid, MBBS (IIUM) — National University of Malaysia
- Study coordinator: Mohamed Faisal Abdul Hamid, MBBS (IIUM)
- Email: faisal.hamid@ppukm.ukm.edu.my
- Phone: 0391455555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease