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Randomized, prospective double-blinded study to evaluate safety and efficacy of Angocin Anti-Infekt N versus placebo in the prophylaxis of respiratory tract infections - AngoPA

Randomized, prospective double-blinded study to evaluate safety and efficacy of Angocin Anti-Infekt N versus placebo in the prophylaxis of respiratory tract infections - AngoPA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-023227-26-DE
Enrollment
Unknown
Registered
2010-11-04
Start date
2010-12-17
Completion date
Unknown
Last updated
2012-05-08

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

Conditions

Prophylaxis of respiratory tract infections MedDRA version: 12.1 Level: LLT Classification code 10066740 Term: Acute respiratory tract infection

Interventions

Trade Name: Angocin Anti-Infekt N Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Nasturtium herb powder CAS Number: n.a. Current Sponsor code: n.a. Other descriptive name: Nasturtium her

Sponsors

Repha GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult volunteers of both sexes who have suffered in the previous cold season at least 2 acute infection of the respiratory tract, subjects aged 18 to 75 years, signed ICF (informed consent form) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: serious chronic diseases, serious diseases of the psyche, known hypersensitivity to any of the components of the study medication, simultaneous participation in a clinical study or participation in a clinical trial within the previous 30 days before enrollment, pregnant women, nursing mothers or women planning a pregnancy, women of childbearing age who operate no adequate contraception, subjects with a disease or in a situation that exposed the opinion of the investigator the subjects a significant risk of prejudice the study results or influence them significantly, abnormal laboratory values, taking antibiotics within 3 weeks prior to study implementation, chronic infections of the respiratory tract, allergic rhinitis, influenza and pneumonia vaccine during the study alcohol and drug abuses previous participation in a study within the last 30 days pregnancy and lactation known hypersensitivity of one of the ingredients of the IMP and placebo

Design outcomes

Primary

MeasureTime frame
Main Objective: Number of subjects with a respiratory tract infection during prophylactic administration within the three groups;Secondary Objective: Kind of infection, intensity of the infection and duration of the infection that occurs within the trial;Primary end point(s): The change of the number of subjects with a respiratory tract infection from the beginning to the end of the study in the three application groups.—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026