The Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Propolis and N-Acetylcysteine Compared to Placebo in Adults in Acute Condition with Sputum Production

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: The study assessing the efficacy and safety of a combination of propolis and N‐Acetylcysteine (PropoMucil 600, Abela Pharm; 80mg propolis+600mg NAC) versus placebo in patients with asthma or COPD or bronchitis, with productive cough, one sachet of powder (3g), once daily for a period of 10 days (sachet will be prepared prior to administration, each sachet dissolved in 125ml (1/4 pint) of water.). A prospective, randomized, double‐blind, placebo‐controlled study will include 100 consecutive patients. Empty, used, sachets must returned at the end of the treatment to the study site. CONDITION: Acute and chronic bronchitis Asthma Bronchitis Chronic obstructive pulmonary disease PRIMARY OUTCOME: Determined the patient’s markers of inflammation (by measuring the C‐reactive protein (CRP), fibrinogen and erythrocyte sedimentation rate (ESR)) from the blood samples (by serum assay), as composite primary outcome. Each patient will be assessed by expectorated amount of sputum (ml) by participant diary and collected by container for sputum SECONDARY OUTCOME: Cough effect on the quality of life through LEICESTER COUGH QUESTIONNAIRE‐acute (LCQ‐acute) Patients` compliance using by participant diary Safety of product reported by questionnaire (fill it out for each of patient), special questionnaire created for the purpose of research INCLUSION CRITERIA: 1. Subjects are between the age of 18 and 85 with acute exacerbation of chronic obstructive pulmonary disease (COPD), acute and chronic bronchitis or asthma who have chest symptoms such as cough and sputum production (particularly increased breathlessness and cough, and increased sputum), treating with conventional therapy (corticosteroid and antibiotics) 2. Gender: both males and females 3. Informed, written consent will be obtained from all respondents (patients)
Epistemonikos ID: 7ec73ecd417a101f5adbaa8374c606fc2ecc5f15
First added on: Aug 23, 2024