A Randomised, Open Label, Interventional Study Evaluating the Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients (SyProNAC Trial)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Malaysia
National University of Malaysia
NOT_YET_RECRUITING
Cheras
National University of Malaysia, Faculty of Medicine
RECRUITING
Cheras
Contact Information
Primary
Mohamed Faisal Abdul Hamid, MBBS (IIUM)
faisal.hamid@ppukm.ukm.edu.my
0391455555
Backup
Mohamed FaisalM Abdul Hamid, MBBS (IIUM)
faisal.hamid@ppukm.ukm.edu.my
0391455555
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 100
Treatments
Active_comparator: Participant with stable COPD who received Syrup prospan
Participant who fulfiled inclusion criteria with stable COPD and received Syrup prospan for 1 month
Active_comparator: Participant with stable COPD who received N-Acetylcysteine
Participant who fulfiled inclusion criteria with stable COPD and received SN-Acetylcysteine for 1 month
Sponsors
Leads: National University of Malaysia

This content was sourced from clinicaltrials.gov