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

NCT07030855 | Enrolling By Invitation Phase 4 DMC

• 2 other identifiers: NNGYK/ETGY/03198-4/20252025-520845-61-00
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Acute Bronchitis

Keywords

Elixirium thymi compositum; thyme; Bronchitis Severity Score; pediatric; bronchitis

Outcome Measures

Primary Outcomes (1)

• Bronchitis Severity Score

  The Bronchitis Severity Scale (BSS) is a tool that assesses the five most important symptoms of acute bronchitis: cough, sputum production, wheezing, chest pain on coughing, and dyspnea. The assessment is based on the examiner's clinical judgment and patient feedback. The examiner rates each parameter of the BSS on a 5-point verbal scale from 0 to 4 (0: absent; 1: mild; 2: moderate; 3: severe; 4: very severe). The total BSS score is the sum of the ratings of the five symptoms, with a maximum score of 20.

  From enrollment to the end of study at 7 days, measured on Day 0, Day 3 and Day 7.

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From enrollment to the end of study at 7 days.

• Quality of life in acute bronchitis

  From enrollment to the end of study at 7 days.

Study Arms (2)

Elixirium thymi compositum

EXPERIMENTAL

For 6-9 years old patients, 6 ml oral solution three times a day for 5 days. For 9-15 years old patients, 8 ml oral solution three times a day for 5 days. For 15-17 years old patients, 10 ml oral solution three times a day for 5 days.

Combination Product: Elixirium thymi compositum (FoNo VIII.)

Elixirium thymi compositum placebo

PLACEBO COMPARATOR

A placebo identical in appearance (color) and taste to the investigational product, without the active ingredient (thyme tincture). For 6-9 years old patients, 6 ml oral solution three times a day for 5 days. For 9-15 years old patients, 8 ml oral solution three times a day for 5 days. For 15-17 years old patients, 10 ml oral solution three times a day for 5 days.

Combination Product: Elixirium thymi compositum (FoNo VIII.) placebo

Interventions

Elixirium thymi compositum (FoNo VIII.) COMBINATION_PRODUCT

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.

Elixirium thymi compositum

Elixirium thymi compositum (FoNo VIII.) placebo COMBINATION_PRODUCT

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.

Elixirium thymi compositum placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 6-17 years,
• diagnosis of acute bronchitis and the Total Bronchitis Severity Score of the patient is between 5-12 points,
• informed consent form and patient information leaflet signed by the patient and the parent or legal guardian, and
• no pregnancy, no planned pregnancy, and no breastfeeding.

You may not qualify if:

• allergy to the active ingredients or any other components of Elixirium thymi compositum,
• hypersensitivity to plants of the Lamiaceae family,
• chronic respiratory diseases such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease,
• pneumonia in the last year,
• a history of recurrent or severe laryngotracheal stenosis due to inflammation,.
• active or chronic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or infectious enterocolitis,
• heart failure (New York Heart Association Class II-IV),
• smoking (the patient currently smokes or has smoked at least one cigarette, cigar, or pipe daily),
• a diagnosis or history of lung cancer,
• a history of lung or chest surgery,
• epilepsy,
• any viral infection in the last 6-8 weeks,
• immunostimulant medications, antibiotics, or systemic steroid treatments in the past month,
• antihistamines, expectorants, or local steroids applied in the last two weeks,
• hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency,

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Noé Medical Center

Szeged, Hungary

Location

Related Publications (15)

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MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled study

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)