Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients
NCT ID: NCT07030855
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE4
56 participants
INTERVENTIONAL
2025-07-31
2027-12-31
Brief Summary
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Detailed Description
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The aim is to establish the role of this product by evaluating its clinical efficacy and safety, meanwhile reducing the misuse of antibiotics in treating this condition.
This is a randomized, controlled, double-blinded, two-arm multicenter phase 4 trial. Eligible patients will be pediatric individuals between 6 and 17 years old diagnosed with acute bronchitis. The trial will enroll at least 56 eligible participants with a Total Bronchitis Severity Score (BSS) ranging from 5 to 12 points. Participants will be assigned randomly in a 1:1 ratio to receive either Elixirium thymi compositum at an age-dependent dosage (18-30 ml daily) for 5 days or a placebo with the same concentration and duration.
The trial's primary endpoint is the assessment of symptom improvement in acute bronchitis, as indicated by changes in the BSS score on Day 7. Secondary endpoints include evaluating use of concomitant medications and dietary supplements, safety and tolerability through reported adverse events, and the necessity of antibiotic usage. These secondary endpoints will provide deeper insights into the differences between the treatment and placebo groups. The primary and secondary endpoints will be monitored throughout a follow-up period of 7 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elixirium thymi compositum
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.
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.
Elixirium thymi compositum placebo
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. diagnosis of acute bronchitis and the Total Bronchitis Severity Score 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
2. hypersensitivity to plants of the Lamiaceae family,
3. chronic respiratory diseases such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease,
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 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.
6 Years
17 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Locations
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Noé Medical Center
Szeged, , Hungary
Countries
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References
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Saust LT, Bjerrum L, Siersma V, Arpi M, Hansen MP. Quality assessment in general practice: diagnosis and antibiotic treatment of acute respiratory tract infections. Scand J Prim Health Care. 2018 Dec;36(4):372-379. doi: 10.1080/02813432.2018.1523996. Epub 2018 Oct 8.
Braman SS. Chronic cough due to acute bronchitis: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):95S-103S. doi: 10.1378/chest.129.1_suppl.95S.
Cutrera R, Baraldi E, Indinnimeo L, Miraglia Del Giudice M, Piacentini G, Scaglione F, Ullmann N, Moschino L, Galdo F, Duse M. Management of acute respiratory diseases in the pediatric population: the role of oral corticosteroids. Ital J Pediatr. 2017 Mar 23;43(1):31. doi: 10.1186/s13052-017-0348-x.
Gonzales R, Sande MA. Uncomplicated acute bronchitis. Ann Intern Med. 2000 Dec 19;133(12):981-91. doi: 10.7326/0003-4819-133-12-200012190-00014.
Snyder RL, King LM, Hersh AL, Fleming-Dutra KE. Unnecessary antibiotic prescribing in pediatric ambulatory care visits for bronchitis and bronchiolitis in the United States, 2006-2015. Infect Control Hosp Epidemiol. 2021 May;42(5):612-615. doi: 10.1017/ice.2020.1231. Epub 2020 Oct 16.
Wenzel RP, Fowler AA 3rd. Clinical practice. Acute bronchitis. N Engl J Med. 2006 Nov 16;355(20):2125-30. doi: 10.1056/NEJMcp061493. No abstract available.
Gonzales R, Bartlett JG, Besser RE, Cooper RJ, Hickner JM, Hoffman JR, Sande MA; Centers for Disease Control and Prevention. Principles of appropriate antibiotic use for treatment of uncomplicated acute bronchitis: background. Ann Emerg Med. 2001 Jun;37(6):720-7. doi: 10.1067/S0196-0644(01)70091-1.
Kowalczyk A, Przychodna M, Sopata S, Bodalska A, Fecka I. Thymol and Thyme Essential Oil-New Insights into Selected Therapeutic Applications. Molecules. 2020 Sep 9;25(18):4125. doi: 10.3390/molecules25184125.
Ludwig S, Stier H, Weykam S. Evaluation of Blood Alcohol Concentrations after Oral Administration of a Fixed Combination of Thyme Herb and Primrose Root Fluid Extract to Children with Acute Bronchitis. Drug Res (Stuttg). 2016 Feb;66(2):69-73. doi: 10.1055/s-0034-1398543. Epub 2015 Feb 17.
Kamin W, Maydannik VG, Malek FA, Kieser M. Efficacy and tolerability of EPs 7630 in patients (aged 6-18 years old) with acute bronchitis. Acta Paediatr. 2010 Apr;99(4):537-43. doi: 10.1111/j.1651-2227.2009.01656.x. Epub 2010 Jan 11.
Gruenwald J, Graubaum HJ, Busch R. Evaluation of the non-inferiority of a fixed combination of thyme fluid- and primrose root extract in comparison to a fixed combination of thyme fluid extract and primrose root tincture in patients with acute bronchitis. A single-blind, randomized, bi-centric clinical trial. Arzneimittelforschung. 2006;56(8):574-81. doi: 10.1055/s-0031-1296754.
Kardos P, Bittner CB, Seibel J, Abramov-Sommariva D, Birring SS. Effectiveness and tolerability of the thyme/ivy herbal fluid extract BNO 1200 for the treatment of acute cough: an observational pharmacy-based study. Curr Med Res Opin. 2021 Oct;37(10):1837-1844. doi: 10.1080/03007995.2021.1960493. Epub 2021 Aug 13.
Kemmerich B, Eberhardt R, Stammer H. Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittelforschung. 2006;56(9):652-60. doi: 10.1055/s-0031-1296767.
Haidvogl M, Heger M. Treatment effect and safety of EPs 7630-solution in acute bronchitis in childhood: report of a multicentre observational study. Phytomedicine. 2007;14 Suppl 6:60-4. doi: 10.1016/j.phymed.2006.11.014. Epub 2006 Dec 20.
Matthys H, Kamin W, Funk P, Heger M. Pelargonium sidoides preparation (EPs 7630) in the treatment of acute bronchitis in adults and children. Phytomedicine. 2007;14 Suppl 6:69-73. doi: 10.1016/j.phymed.2006.11.015. Epub 2006 Dec 20.
Other Identifiers
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2025-520845-61-00
Identifier Type: CTIS
Identifier Source: secondary_id
NNGYK/ETGY/03198-4/2025
Identifier Type: -
Identifier Source: org_study_id
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