Trials / Completed
CompletedNCT06142994
Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting
Phase 4, Efficacy and Safety of Atusin CAP in the Treatment of Subjects With Acute Bronchitis in the Primary Healthcare Setting: Prospective, Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-arm Clinical Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 310 (actual)
- Sponsor
- Neopharm Bulgaria Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The study aims to evaluate the effectiveness and safety of Atusin® CAP in reducing the severity of acute bronchitis.
Detailed description
A prospective, multicenter, double-blind, placebo-controlled, randomized, parallel study will be conducted to evaluate the effect of Atusin® CAP on the rapid relief of irritating cough in adults with acute bronchitis treated in actual clinical practices in primary healthcare, where patients seek help as a result of serious complaints. The combination of the three extracts: a mix of essential oils, bromelain and green Brazilian propolis may represent a breakthrough in symptomatic treatment by blocking the triggering mechanisms of cough due to acute bronchitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Atusin CAP | This food supplement contains a distillate of 4 types of purified oils - eucalyptus, sweet orange, lemon and myrtle, rich in 1,8-cineol, limonene, alpha-pinene in the ratio: 66:32:1:1, bromelain and green Brazilian propolis in a gastro-resistant capsule. The product contains excipients: microcrystalline cellulose, silica dioxide, copovidone, magnesium stearate. |
| DIETARY_SUPPLEMENT | Placebo | The placebo product will be identical in shape, appearance and color to the active product and will have the same composition but without the active ingredients. |
Timeline
- Start date
- 2024-01-30
- Primary completion
- 2024-06-20
- Completion
- 2024-06-20
- First posted
- 2023-11-22
- Last updated
- 2024-10-30
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT06142994. Inclusion in this directory is not an endorsement.