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ENROLLING BY INVITATION
NCT07030855
PHASE4

Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients

Sponsor: Semmelweis University

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate the efficacy and safety of Elixirium thymi compositum (Formulae Normales (FoNo) VIII.) compared to a placebo in children between 6 and 17 years old to treat their acute bronchitis. The main question it aims to answer is: Is Elixirium thymi compositum (FoNo VIII.) safe and effective in the treatment of acute bronchitis compared to placebo?

Official title: Assessing the Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients (EXOTIC): A Double-blind, Randomized, Placebo-controlled, Phase 4 Study

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-07

Completion Date

2027-12

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Elixirium thymi compositum (FoNo VIII.)

During the study, the dosage is for children and adolescents as follows: 6 ml three times a day for 6-9 years, 8 ml three times a day for 9-15 years, and 10 ml three times a day for 15-17 years.

COMBINATION_PRODUCT

Elixirium thymi compositum (FoNo VIII.) placebo

During the study, the dosage is for children and adolescents as follows: 6 ml three times a day for 6-9 years, 8 ml three times a day for 9-15 years, and 10 ml three times a day for 15-17 years.

Locations (1)

Noé Medical Center

Szeged, Hungary