Acute BronchitisPhase 4EXOTICNCT07030855
Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients
A Phase 4 study testing Elixirium thymi compositum (FoNo VIII.) in people with Acute Bronchitis, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- Elixirium thymi compositum (FoNo VIII.)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteHungary
- Study dates
- Jul 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 17Show fewer
- 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,
- taking or planning to take hormonal contraceptives within the next 2 weeks
- chronic liver disease (e.g., cirrhosis) or acute hepatitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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?
Read the detailed description
Acute bronchitis 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, 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
- Acute Bronchitis
- Being tested
- Elixirium thymi compositum (FoNo VIII.), Elixirium thymi compositum (FoNo VIII.) placebo
- Keywords
- Elixirium thymi compositum, thyme, Bronchitis Severity Score, pediatric, bronchitis
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (FoNo VIII.) placeboCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Elixirium thymi compositum (FoNo VIII.) placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
Any adverse events and concomitant medications during the 7-day period.
Measured: From enrollment to the end of study at 7 days.
Quality of life in acute bronchitis
Quality of life in patients with acute bronchitis was assessed using the Quality of Life Questionnaire, which measures the physical, psychological, and social impact of symptoms during illness. Each question is scored from 1 (absent symptom) to 5 (very severe symptom). Domain scores are calculated as the average of item scores within each domain (Physical: 6 items, Psychological: 7 items, Social: 5 items), resulting in a range of 1 to 5 per domain. The total score, obtained by summing the three domain scores, ranges from 3 (best possible quality of life) to 15 (worst possible quality of life).
Measured: From enrollment to the end of study at 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acute BronchitisStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030855
- Sponsor's protocol ID
- NNGYK/ETGY/03198-4/2025
- Other IDs
- 2025-520845-61-00, 2025
- Acronym
- EXOTIC
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available for this study. The informed consent form, in compliance with the EU General Data Protection Regulation (GDPR) and relevant Hungarian laws, specifically informs participants that their data will be handled confidentially, stored anonymously, and presented only in aggregate, anonymized form in any resulting publications. The consent does not include permission for broader sharing of individual-level data outside the study team or approved data processors.
Publications
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.
PubMed 30296885Braman 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.
PubMed 16428698Cutrera 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.
PubMed 28335827Gonzales 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.
PubMed 11119400Snyder 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.
PubMed 33059780Wenzel 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.
PubMed 17108344Gonzales 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.
PubMed 11385346Kowalczyk 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.
PubMed 32917001Ludwig 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.
PubMed 25823507Kamin 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.
PubMed 20070280Gruenwald 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.
PubMed 17009838Kardos 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.
PubMed 34340607Kemmerich 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.
PubMed 17063641Haidvogl 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.
PubMed 17184982Matthys 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.
PubMed 17184981
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07030855
- Acronym / sponsor ID
- EXOTIC / NNGYK/ETGY/03198-4/2025
- Conditions
- Acute Bronchitis
- Keywords
- Elixirium thymi compositum, thyme, Bronchitis Severity Score, pediatric, bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Acute bronchitis 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Elixirium thymi compositum | Experimental | Combination Product: Elixirium thymi compositum (FoNo VIII.)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 placebo | Placebo comparator | Combination Product: Elixirium thymi compositum (FoNo VIII.) placeboA 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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,.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| Elixirium thymi compositum (FoNo VIII.) placeboDuring 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 placebo |
Primary outcome
Bronchitis Severity Score
Time frame: From enrollment to the end of study at 7 days, measured on Day 0, Day 3 and Day 7.
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.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From enrollment to the end of study at 7 days.
Quality of life in acute bronchitis
Time frame: From enrollment to the end of study at 7 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 30296885Saust 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.
- Background: PubMed 16428698Braman 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.
- Background: PubMed 28335827Cutrera 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.
- Background: PubMed 11119400Gonzales 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.
- Background: PubMed 33059780Snyder 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.
- Background: PubMed 17108344Wenzel 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.
- Background: PubMed 11385346Gonzales 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.
- Background: PubMed 32917001Kowalczyk 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.
- Background: PubMed 25823507Ludwig 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.
- Background: PubMed 20070280Kamin 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.
- Background: PubMed 17009838Gruenwald 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.
- Background: PubMed 34340607Kardos 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.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available for this study. The informed consent form, in compliance with the EU General Data Protection Regulation (GDPR) and relevant Hungarian laws, specifically informs participants that their data will be handled confidentially, stored anonymously, and presented only in aggregate, anonymized form in any resulting publications. The consent does not include permission for broader sharing of individual-level data outside the study team or approved data processors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elixirium thymi compositum (FoNo VIII.) in people with Acute Bronchitis, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchitis Severity Score (time frame: From enrollment to the end of study at 7 days, measured on Day 0, Day 3 and Day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07030855, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.