Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT06377410

Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients

Led by National University of Malaysia · Updated on 2025-11-19

100

Participants Needed

2

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with documented post bronchodilator FEV1/FVC < 70 or below the lower limit of normal
  • Age 40 years and above
  • Able to perform spirometry
  • Stable COPD based on GOLD 2023 strategy
Not Eligible

You will not qualify if you...

  • Diagnosis of other chronic lung diseases such as Asthma, Asthma-COPD Overlap, Interstitial Lung Disease, Bronchiectasis, or Lung Cancer
  • Contraindications for spirometry including recent cardiac complications, major surgery, severe advanced respiratory disease, or cognitive/neurological impairment
  • Hypersensitivity to acetylcysteine or any component of the formulation
  • Hypersensitivity to dry powder ivy extract
  • Pregnant or nursing (lactating) women
  • Use of regular mucolytics for at least one month before the study
  • Illiteracy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

National University of Malaysia, Faculty of Medicine

Cheras, Kuala Lumpur, Malaysia, 56000

Actively Recruiting

2

National University of Malaysia

Cheras, Kuala Lumpur, Malaysia, 56000

Not Yet Recruiting

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Research Team

M

Mohamed Faisal Abdul Hamid, MBBS (IIUM)

CONTACT

M

Mohamed FaisalM Abdul Hamid, MBBS (IIUM)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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