Clinical trial • Phase IV • Infectious Disease|Respiratory

LIQUID EXTRACT OF THYME (1:3.45-3.85), EXTRACTION SOLVENT: ETHANOL 27%(V/V) for Acute bronchitis

Phase IV trial of LIQUID EXTRACT OF THYME (1:3.45-3.85), EXTRACTION SOLVENT: ETHANOL 27%(V/V) for Acute bronchitis.

Overview

Trial Therapeutic Area
Infectious Disease|Respiratory
Trial Disease
Acute bronchitis
Trial Stage
Phase IV
Drug Modality
Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
04-02-2025
First CTIS Authorization Date
07-05-2025

Trial design

Randomised, placebo: elixirium thymi compositum (fono viii.) placebo; active: elixirium thymi compositum fono viii. naturland oral solution — max daily dose 30 ml, max total dose 150 ml, max treatment period 5 days-controlled Phase IV trial across 2 sites in Hungary.

Randomised
Yes
Comparator
Placebo: Elixirium thymi compositum (fono viii.) placebo; Active: Elixirium thymi compositum FoNo VIII. Naturland oral solution — max daily dose 30 ml, max total dose 150 ml, max treatment period 5 days
Target Sample Size
56

Eligibility

Recruits 56 paediatric patients.

Vulnerable Population
Vulnerable population selected: children aged 6-17. Subject information and informed consent forms are provided for age groups 6-9, 6-10, 11-14 and 15-17 (multiple HU versions listed) and L2 other subject information materials; indicates age-appropriate ICF/SIS and assent/consent documentation are prepared (specific consenting party or process not explicitly described in the record).

Inclusion criteria

  • {"criterion_text":"-Children (6-17 y.o.) with acute bronchitis with BSS score between 5-12"}

Exclusion criteria

  • {"criterion_text":"-Allergy to the product, history of chronic respiratory diseases, heart failure, recent viral diseases, smoking, lung cancer, recent lung/chest surgery, and recent treatments with immunostimulants, antibiotics, steroids, antihistamines or expectorants."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Efficacy of the investigational product based on the Bronchitis Severity Score","definition_or_measurement_approach":"Based on the Bronchitis Severity Score (BSS)"}

Secondary endpoints

  • {"endpoint_text":"-Safety and tolerability by the reported adverse events","definition_or_measurement_approach":"Assessed by reported adverse events (AE reporting); safety and tolerability evaluated via reported AEs"}

Recruitment

Planned Sample Size
56
Recruitment Window Months
13
Consent Approach
Age-specific subject information and informed consent forms available for groups 6-9, 6-10, 11-14 and 15-17 (multiple Hungarian versions listed). L2 list of Part II documents available in English. The record lists ICF/SIS documents by age group, indicating assent/consent materials are prepared, but the specific consenting party (e.g., parent/guardian consent and child assent) and exact languages beyond Hungarian/English are not explicitly specified in the record.

Geography

Total Number Of Sites
2
Total Number Of Participants
56

Hungary

Earliest CTIS Part Ii Submission Date
25-03-2025
Latest Decision Or Authorization Date
07-05-2025
Processing Time Days
43
Number Of Sites
2
Number Of Participants
56

Sites

Site Name
Noé Egészségközpont
Department Name
Noé Egészségközpont
Contact Person Name
Rita Román
Contact Person Email
info@noepraxis.hu
Site Name
Noé Egészségközpont
Department Name
Noé Egészségközpont
Contact Person Name
Zsolt Bella
Contact Person Email
info@noepraxis.hu

Sponsor

Primary sponsor

Full Name
Semmelweis University
Organisation Type
Educational Institution
Country Of Registered Address
Hungary

Investigational products

Investigational Product Name
Elixirium thymi compositum FoNo VIII. Naturland belsőleges oldat
Active Substance
LIQUID EXTRACT OF THYME (1:3.45-3.85), EXTRACTION SOLVENT: ETHANOL 27%(V/V)
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation OGYI-TN-73/01)
Maximum Dose
max daily dose 30 ml; max total dose 150 ml
Investigational Product Name
Elixirium thymi compositum (fono viii.) placebo
Modality
Other

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