Study title: Three randomized, double blind, placebo-controlled clinical trials: Efficacy and tolerability of Pelargonium extract EPsĀ® 7630 in patients (1-18 resp. 6-18 years old) with acute bronchitis.
Type of medicine: Herbal and homoeopathic medicines | |||||
Therapeutic area: Respiratory Tract Diseases [C08] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: HERB: 800 mg ethanolic extract (1+10) from the roots of Pelargonium reniforme/sidoides./ HERB: extract from the roots of Pelargonium sidoides (1 : 8 - 10)./ HERB: extract from the roots of Pelargonium sidoides (1 : 8 - 10); extraction agent: ethanol 11% (m/m)./ HERB: extract from the roots of Pelargonium sidoides (1 : 9 - 11); extraction agent: ethanol 11% (m/m). | |||||
ATC code: R05 | |||||
Document link: | |||||
Document date: | |||||
Study number: 701003.01.001 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | Y | Y |