cough
Conditions
Interventions
Trade Name: Tussavit
Product Name: Tussavit
Pharmaceutical Form: Syrup
INN or Proposed INN: Thyme Fluid Extract,Ribwort (Plantain) Fluid Extract
Concentration unit: g/ml gram(s)/millilitre
Concentrati
Sponsors
Pharmazeutische Fabrik Montavit Ges.m.b.H.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults, adolescents and children from the age of 2 years on, presentation of cough in respiratory system diseases due to different etiology, informed consent and willingness to comply with the protocol. Are the trial subjects under 18? yes 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known or suspected hypersensitivity to Tussavit, to thyme and/or plantain and/or to any of the excipients, antibiotic therapy at any time during the proceeding four weeks, application of concomitant medications including antibiotic preparations, mucolytics, expectorants other then study medication, corticosteroids and bronchodilatatory agents, diabetes, asthma, history of alcohol or drug abuse likely to lead to uncooperative behavior, history of psychiatric illness likely to lead to uncooperative behavior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Valuation of the efficacy, safety, acceptability and assistance to treatment with Tussavit;Secondary Objective: Valuation of the symptoms of FEO1 and FVK at the fourth day; valuation of the amount of sputums in ml at the fourth day; valuation of the symptoms of FEO1 and FVK at the eleventh day; valuation of unwanted reactions; the effect to smokers;Primary end point(s): Evaluation of influence of three days of treatment with Tussavit on expectoration (general improvement yes/no) | — |
Countries
Bulgaria
Outcome results
None listed