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Pharmacy based non-interventional study (NIS) assessing the efficacy and safety of Esberitox® COMPACT in case of colds

Pharmacy based non-interventional study (NIS) assessing the efficacy and safety of Esberitox® COMPACT in case of colds - SB-TOX 0116

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00011068
Enrollment
800
Registered
2016-09-21
Start date
2016-09-23
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Viral cold diseases J06.9

Interventions

Group 1: Patients with acute cold symptoms who opted for treatment with Esberitox® COMPACT will record their disease progression over maximum 10 treatment days in a cold diary. The package leaflet of

Sponsors

Schaper & Brümmer GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients who intend to treat their acute cold with Esberitox® COMPACT in line with the package information leaflet and who are invited by the pharmacist / the qualified staff to participate in the study. - Written data collection consent has been obtained.

Exclusion criteria

Exclusion criteria: Contraindications of Esberitox® COMPACT according to the package information leaflet.

Design outcomes

Primary

MeasureTime frame
Assessment of the risk-benefit ratio of Esberitox® COMPACT under everyday conditions by using a cold diary and by - collection of essential cold symptoms (global cold; rhinitis score; bronchitis score; general complaints; total score) at treatment start and every 1 – 2 days during the maximum 10-day treatment and of the overall assessment of efficacy after the last application by the patient ('benefit') - collection of adverse drug reactions during the course of treatment and of the overall assessment of tolerability after the last application by the patient ('risk').

Secondary

MeasureTime frame
Collection of the overall assessment of patient satisfaction with the treatment after the last application by using a cold diary.

Countries

Germany

Contacts

Public ContactJörg Schnitker

Institut für angewandte Statistik Dr. Jörg Schnitker GmbH (IAS)

info@ias-cro.de0521 / 56088-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 21, 2026