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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000344392
Enrollment
100
Registered
2017-03-06
Start date
2017-03-21
Completion date
2017-10-02
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Efficacy and safety of a combination of propolis and N-Acetylcysteine (NAC); (PropoMucil 600 manufactured by Abela Pharm, Serbia) versus placebo in patients with asthma or COPD, and productive cough for a period of 10 days as measured by the amount of sputum, cough impact on the patient, parameters of inflammation (C-reactive protein, erythrocyte sedimentation rate).

Interventions

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 patie

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.

Sponsors

Abela Pharm
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Exclusion criteria

1. status asthmaticus 2. history of stomach or duodenal ulcer 3. <18 years of age 4. patients who are sensitive to NAC and propolis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026