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

Launched by SEMMELWEIS UNIVERSITY · Jun 12, 2025

Keywords

ClinConnect Summary

Acute bronchitis (AB) is a common disease caused mainly by viral infections. Although there is a standard symptomatic therapy for it, antibiotics are often prescribed, which contributes to an increase in antibiotic resistance. Elixirium thymi compositum (FoNo VIII.) might be an alternative therapeutic option.

The aim is to establish the role of this product by evaluating its clinical efficacy and safety (FoNo VIII.), meanwhile reducing the misuse of antibiotics in treating this condition.

This is a randomized, controlled, double-blinded, two-armed multicenter phase 4 trial. Eligible patie...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age 6-17 years,
• • 2. diagnosis of AB and the Total BSS of the patient is between 5-12 points,
• • 3. informed consent form and patient information leaflet signed by the patient and the parent or legal guardian, and
• • 4. no pregnancy, no planned pregnancy, and no breastfeeding.
• Exclusion Criteria:
• • 1. allergy to the active ingredients or any other components of ETC,
• • 2. hypersensitivity to plants of the Lamiaceae family,
• • 3. chronic respiratory diseases such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease (COPD),
• • 4. pneumonia in the last year,
• • 5. a history of recurrent or severe laryngotracheal stenosis due to inflammation,.
• • 6. active or chronic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or infectious enterocolitis,
• • 7. heart failure (New York Heart Association (NYHA) Class II-IV),
• • 8. smoking (the patient currently smokes or has smoked at least one cigarette, cigar, or pipe daily),
• • 9. a diagnosis or history of lung cancer,
• • 10. a history of lung or chest surgery,
• • 11. epilepsy,
• • 12. any viral infection in the last 6-8 weeks,
• • 13. immunostimulant medications, antibiotics, or systemic steroid treatments in the past month,
• • 14. antihistamines, expectorants, or local steroids applied in the last two weeks,
• • 15. hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency,
• • 16. taking or planning to take hormonal contraceptives within the next 2 weeks
• • 17. chronic liver disease (e.g., cirrhosis) or acute hepatitis.