Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorNational University of Malaysia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Syrup Prospan
DrugParticipant with stable COPD who received Syrup prospan for 1 month
N-Acetylcysteine
DrugParticipant with stable COPD who received N-Acetylcysteine for 1 month
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Participant with stable COPD who received Syrup prospanActive comparator 1 intervention
Group B: Participant with stable COPD who received N-AcetylcysteineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Time frame
From the time of randomization to the time of the end of study up to 30 days post randomizationSecondary outcomes
1
to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life.
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Time frame
From the time of randomization to the time of the end of study up to 30 days post randomization2
to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Time frame
From the time of randomization to the time of the end of study up to 30 days post randomization3
to determine change of Forced Vital Capacity in litres/minute using spirometry
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Time frame
From the time of randomization to the time of the end of study up to 30 days post randomization4
to determine adverse effects of Syrup Prospan (in %)
Participants with COPD who received Syrup Prospan
Time frame
From the time of randomization to the time of the end of study up to 30 days post randomizationLocations
2Map coordinates are unavailable for these locations. Locations are shown below instead.
National University of MalaysiaNot yet recruiting56000, Cheras, Kuala Lumpur
Malaysia
MalaysiaNational University of Malaysia, Faculty of MedicineRecruiting56000, Cheras, Kuala LumpurMalaysia
MalaysiaSponsors and contacts
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Source ClinicalTrials.gov