Respiratory InflammationPhase 4NCT07518394
Oral Essential Oils Efficacy in Acute Respiratory Symptoms
A Phase 4 study testing essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree in people with Respiratory Inflammation, run by University of Sfax at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to explore the impact of a dietary supplement containing essential oils on symptom severity in patients presenting to the ED with respiratory complaints. It will also learn about the safety of this diet supplement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Inflammation
- What is being tested?
- essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2023to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients presenting with acute cough and at least one of the following symptoms: sputum production, dyspnea, wheezing, or chest discomfort/pain
- No alternative explanation for symptoms
Who cannot join
- Non-communicating patients
- Pregnant patients
- Patients with known allergy to study components
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Habib Bourguiba University Hospital, Sfax
Sfax, Sfax Governorate, 3029
About this study
Official title: Using Botanical Ingestible Oils for Treating Infectious Conditions: The UBIOTIC Study on Essential Oils for Lower Respiratory Infections in the Emergency Department
The goal of this clinical trial is to explore the impact of a dietary supplement containing essential oils on symptom severity in patients presenting to the ED with respiratory complaints. It will also learn about the safety of this diet supplement. The main question it aims to answer is :
- Does Ubiotique lower the severity of symptoms (cough, sputum, fatigue) in patients presenting to the emergency department with respiratory complaints.
Read more
Researchers will compare drug Ubiotique to a placebo (a look-alike substance that contains no drug) to see if drug Ubiotique works to reduce symptoms (Cough, sputum, fatigue).
Participants will:
- Take Ubiotique or a placebo three times per day for ten days
- Be phone-called to be followed-up at day 3, 5, and 7post emergency visit
- Keep a diary of their symptoms and give a score to the severity of each symptom
Read the detailed description
Patients treated with Essential oil treatment and placebo received 1 capsule 3 times per day. At the end of management at the ED, the investigator gave the caps box to the patient and explained the follow-up process. The investigator phoned the patients on days 1, 3, 5, 7, and 10 of the ED visits to complete their follow-up. No other changes in the management were indicated. No extra tests were required for the trial. All the clinical, radiological, and biological data were recorded. There were no further changes in the prescribed treatments at discharge.
Outcomes measures: The primary study endpoint was the benefits of Essential Oil in reducing symptoms' severity (cough, sputum, fatigue). The severity of these symptoms was self-reported by the patient on a 5-point Likert scale (0 = not present, 1 = somewhat present, 2 = present, 3 = present and challenging, 4= Always present and highly challenging). The difference in symptom severity between Day 3, Day 5, Day 7, and the baseline severity of the three main symptoms (Cough, sputum, fatigue) was calculated for each patient. The value was negative if there was a decrease in the symptom severity and positive when the symptom severity increased. These values were compared in the two groups of patients to assess the decrease in symptoms' severity.
The secondary endpoints included safety and adherence to the treatment, and the presence of adverse events. Serious adverse events or reactions (death, life-threatening condition during the study period, unplanned hospitalization, unplanned prolongation of the current hospitalization, persistent disability) were recorded during the follow-up of all the patients. Unfavorable symptoms were also evaluated; the participants were asked if they experienced any changes or symptoms (smell, gastrointestinal symptoms, transit abnormality, urinary tract symptoms). If yes, they were asked to rate the symptom from 0 to 3.
- Conditions
- Respiratory Inflammation
- Being tested
- essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree, placebo of the essential oil capsule
- Keywords
- Essential Oil, Dietary Supplement, Low Tract Respiratory Infection, Symptom Management, Respiratory Complaints, Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor treeDietary supplement
The essential oil capsule used in this study is a commercially available product that can be purchased without a prescription; however, it is not included in conventional or academic treatment protocols for lower respiratory infections and was evaluated in this trial solely for research purposes. Participants randomized to the intervention group received an oral capsule containing a combination of botanical essential oils, including eucalyptus (20 mg), thyme (20 mg), cinnamon (10 mg), lavender (20 mg), winter savory (20 mg), tea tree (20 mg), and camphor tree (20 mg). Participants in the control group received a placebo capsule identical in appearance, taste, smell, consistency, and packaging. Study medication was administered at a dose of one capsule three times daily for a total duration of 10 days. The study capsules were provided by the investigator at the time of emergency department discharge, and participants received standardized instructions regarding treatment administration.
placebo of the essential oil capsuleDietary supplement
the placebo capsule were identical in color, taste, smell, consistency, and packaging and do not contains essential oils.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | this group will be invited to take a placebo capsule in addition to the standard treatment prescribed at discharge from the emergency department Receives: Dietary Supplement: placebo of the essential oil capsule |
| Essential oil group | Active comparator | this group will be invited to take a capsule containing essential oils in addition to the standard treatment prescribed at discharge from the emergency department Receives: Dietary Supplement: essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoint was the benefits of Essential Oil in reducing symptoms (cough, sputum, fatigue).
The severity of these symptoms was self-reported by the patient on a 5-point Likert scale (0 = not present, 1 = somewhat present, 2 = present, 3 = present and challenging, 4= Always present and highly challenging).
As these symptoms are clinically linked, we calculated the total symptom severity score. The sum of the cough, sputum, and fatigue scores was defined as the composite symptoms score. Based on the calculated score, the severity of the symptoms was considered minor (score under 4), moderate (score between 4 and 8), or severe (score 9 or more). For each patient, the difference in symptoms score was calculated between Day 3, Day 5, Day 7, and the baseline severity. The value is negative when symptom severity decreases, and positive when symptom severity increases. The percentage of symptoms remaining at Day 3 was calculated for each participant as the ratio of the Day 3 symptom score to the baseline score, multiplied by 100.
Measured: The investigator phoned the patients on days 1, 3, 5, 7, and 10 of the ED visits to complete their follow-up. No other changes in the management were indicated.
Secondary outcomes (1)
secondary outcomes: • the change of each symptom (cough, sputum, fatigue), • Safety and tolerability of the intervention • Adherence to treatment • Incidence of adverse events
The secondary endpoints were the change of each symptom (cough, sputum, fatigue), safety and adherence to the treatment, and the presence of adverse events. We calculated the difference of each symptom score (cough, sputum, fatigue) between Day 3, Day 5, Day 7, and the baseline for each patient. We recorded serious adverse events or reactions (death, life-threatening conditions during the study period, unplanned hospitalizations, unplanned prolongation of current hospitalizations, persistent disabilities) during the follow-up of all patients. We also assessed unfavourable symptoms; participants were asked whether they experienced any changes or symptoms (smell, gastrointestinal symptoms, transit disturbances, or urinary tract symptoms). If yes, they were asked to rate the symptom from 0 to 3. Approval from the ethics committee was obtained.
Measured: The followup is conducted on Day 3, Day 5, Day 7, by phone call.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Mar 2023
- Primary completion15 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Respiratory InflammationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfa Chakroun-Walha, University of Sfax
- Investigators
- noureddine rekik, professor, head of the departm, Study chair, habib bourguiba university hospial, faculty of medicine sfax university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518394
- Sponsor's protocol ID
- USfax
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu S, Patel KB, Booth LJ, Metcalf JP, Lin HK, Wu W. Protective essential oil attenuates influenza virus infection: an in vitro study in MDCK cells. BMC Complement Altern Med. 2010 Nov 15;10:69. doi: 10.1186/1472-6882-10-69.
PubMed 21078173Kahler C, Derezinski T, Bocian-Sobkowska J, Keckeis A, Zacke G. Spicae aetheroleum in uncomplicated acute bronchitis: a double-blind, randomised clinical trial. Wien Med Wochenschr. 2019 Apr;169(5-6):137-148. doi: 10.1007/s10354-017-0612-0. Epub 2017 Dec 5.
PubMed 29209859Horvath G, Acs K. Essential oils in the treatment of respiratory tract diseases highlighting their role in bacterial infections and their anti-inflammatory action: a review. Flavour Fragr J. 2015 Sep;30(5):331-341. doi: 10.1002/ffj.3252. Epub 2015 May 26.
PubMed 32313366Prall S, Bowles EJ, Bennett K, Cooke CG, Agnew T, Steel A, Hausser T. Effects of essential oils on symptoms and course (duration and severity) of viral respiratory infections in humans: A rapid review. Adv Integr Med. 2020 Dec;7(4):218-221. doi: 10.1016/j.aimed.2020.07.005. Epub 2020 Aug 3.
PubMed 32837899Wani AR, Yadav K, Khursheed A, Rather MA. An updated and comprehensive review of the antiviral potential of essential oils and their chemical constituents with special focus on their mechanism of action against various influenza and coronaviruses. Microb Pathog. 2021 Mar;152:104620. doi: 10.1016/j.micpath.2020.104620. Epub 2020 Nov 16.
PubMed 33212200Tariq S, Wani S, Rasool W, Shafi K, Bhat MA, Prabhakar A, Shalla AH, Rather MA. A comprehensive review of the antibacterial, antifungal and antiviral potential of essential oils and their chemical constituents against drug-resistant microbial pathogens. Microb Pathog. 2019 Sep;134:103580. doi: 10.1016/j.micpath.2019.103580. Epub 2019 Jun 11.
PubMed 31195112Duijker G, Bertsias A, Symvoulakis EK, Moschandreas J, Malliaraki N, Derdas SP, Tsikalas GK, Katerinopoulos HE, Pirintsos SA, Sourvinos G, Castanas E, Lionis C. Reporting effectiveness of an extract of three traditional Cretan herbs on upper respiratory tract infection: results from a double-blind randomized controlled trial. J Ethnopharmacol. 2015 Apr 2;163:157-66. doi: 10.1016/j.jep.2015.01.030. Epub 2015 Jan 30.
PubMed 25645191Gillissen A, Wittig T, Ehmen M, Krezdorn HG, de Mey C. A multi-centre, randomised, double-blind, placebo-controlled clinical trial on the efficacy and tolerability of GeloMyrtol(R) forte in acute bronchitis. Drug Res (Stuttg). 2013 Jan;63(1):19-27. doi: 10.1055/s-0032-1331182. Epub 2013 Jan 8.
PubMed 23447044Rousseau G, Keijzers G, van Meer O, Craig S, Karamercan M, Klim S, Body R, Kuan WS, Harjola VP, Jones P, Verschuren F, Holdgate A, Christ M, Golea A, Capsec J, Barletta C, Graham CA, Garcia-Castrillo L, Laribi S, Kelly AM. Epidemiology, treatment and outcome of patients with lower respiratory tract infection presenting to emergency departments with dyspnoea (AANZDEM and EuroDEM studies). Emerg Med Australas. 2021 Feb;33(1):58-66. doi: 10.1111/1742-6723.13567. Epub 2020 Aug 3.
PubMed 32748553Bel Haj Ali K, Sekma A, Messous S, Trabelsi I, Ben Youssef J, Maghraoui H, Razgallah R, Walha A, Grissa MH, Beltaief K, Mezgar Z, Coubantini A, Bouida W, Msolli MA, Boukef R, Boubaker H, Nouira S. Appropriateness of antibiotic treatment of acute respiratory tract infections in Tunisian primary care and emergency departments: a multicenter cross-sectional study. BMC Prim Care. 2022 Nov 22;23(1):295. doi: 10.1186/s12875-022-01904-7.
PubMed 36418965
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Botanical Ingestible Oils for Treating Infectious Conditions: The UBIOTIC Study on Essential Oils for Lower Respiratory Infections in the Emergency Department
- ClinicalTrials.gov ID
- NCT07518394
- Acronym / sponsor ID
- USfax
- Conditions
- Respiratory Inflammation
- Keywords
- Essential Oil, Dietary Supplement, Low Tract Respiratory Infection, Symptom Management, Respiratory Complaints, Emergency Department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of SfaxUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Apr 2026 (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 goal of this clinical trial is to explore the impact of a dietary supplement containing essential oils on symptom severity in patients presenting to the ED with respiratory complaints. It will also learn about the safety of this diet supplement. The main question it aims to answer is :
- Does Ubiotique lower the severity of symptoms (cough, sputum, fatigue) in patients presenting to the emergency department with respiratory complaints.
Researchers will compare drug Ubiotique to a placebo (a look-alike substance that contains no drug) to see if drug Ubiotique works to reduce symptoms (Cough, sputum, fatigue).
Participants will:
- Take Ubiotique or a placebo three times per day for ten days
- Be phone-called to be followed-up at day 3, 5, and 7post emergency visit
- Keep a diary of their symptoms and give a score to the severity of each symptom
Detailed description
Patients treated with Essential oil treatment and placebo received 1 capsule 3 times per day. At the end of management at the ED, the investigator gave the caps box to the patient and explained the follow-up process. The investigator phoned the patients on days 1, 3, 5, 7, and 10 of the ED visits to complete their follow-up. No other changes in the management were indicated. No extra tests were required for the trial. All the clinical, radiological, and biological data were recorded. There were no further changes in the prescribed treatments at discharge.
Outcomes measures: The primary study endpoint was the benefits of Essential Oil in reducing symptoms' severity (cough, sputum, fatigue). The severity of these symptoms was self-reported by the patient on a 5-point Likert scale (0 = not present, 1 = somewhat present, 2 = present, 3 = present and challenging, 4= Always present and highly challenging). The difference in symptom severity between Day 3, Day 5, Day 7, and the baseline severity of the three main symptoms (Cough, sputum, fatigue) was calculated for each patient. The value was negative if there was a decrease in the symptom severity and positive when the symptom severity increased. These values were compared in the two groups of patients to assess the decrease in symptoms' severity.
The secondary endpoints included safety and adherence to the treatment, and the presence of adverse events. Serious adverse events or reactions (death, life-threatening condition during the study period, unplanned hospitalization, unplanned prolongation of the current hospitalization, persistent disability) were recorded during the follow-up of all the patients. Unfavorable symptoms were also evaluated; the participants were asked if they experienced any changes or symptoms (smell, gastrointestinal symptoms, transit abnormality, urinary tract symptoms). If yes, they were asked to rate the symptom from 0 to 3.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: placebo of the essential oil capsulethis group will be invited to take a placebo capsule in addition to the standard treatment prescribed at discharge from the emergency department |
| Essential oil group | Active comparator | Dietary Supplement: essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor treethis group will be invited to take a capsule containing essential oils in addition to the standard treatment prescribed at discharge from the emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive patients presenting with acute cough and at least one of the following symptoms: sputum production, dyspnea, wheezing, or chest discomfort/pain
- No alternative explanation for symptoms
Key exclusion criteria (3 listed)
- Non-communicating patients
- Pregnant patients
- Patients with known allergy to study components
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 |
|---|---|---|
| essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor treeThe essential oil capsule used in this study is a commercially available product that can be purchased without a prescription; however, it is not included in conventional or academic treatment protocols for lower respiratory infections and was evaluated in this trial solely for research purposes. Participants randomized to the intervention group received an oral capsule containing a combination of botanical essential oils, including eucalyptus (20 mg), thyme (20 mg), cinnamon (10 mg), lavender (20 mg), winter savory (20 mg), tea tree (20 mg), and camphor tree (20 mg). Participants in the control group received a placebo capsule identical in appearance, taste, smell, consistency, and packaging. Study medication was administered at a dose of one capsule three times daily for a total duration of 10 days. The study capsules were provided by the investigator at the time of emergency department discharge, and participants received standardized instructions regarding treatment administration. | Dietary supplement | Essential oil group |
| placebo of the essential oil capsulethe placebo capsule were identical in color, taste, smell, consistency, and packaging and do not contains essential oils. | Dietary supplement | Placebo |
Primary outcome
The primary study endpoint was the benefits of Essential Oil in reducing symptoms (cough, sputum, fatigue).
Time frame: The investigator phoned the patients on days 1, 3, 5, 7, and 10 of the ED visits to complete their follow-up. No other changes in the management were indicated.
The severity of these symptoms was self-reported by the patient on a 5-point Likert scale (0 = not present, 1 = somewhat present, 2 = present, 3 = present and challenging, 4= Always present and highly challenging). As these symptoms are clinically linked, we calculated the total symptom severity score. The sum of the cough, sputum, and fatigue scores was defined as the composite symptoms score. Based on the calculated score, the severity of the symptoms was considered minor (score under 4), moderate (score between 4 and 8), or severe (score 9 or more). For each patient, the difference in symptoms score was calculated between Day 3, Day 5, Day 7, and the baseline severity. The value is negative when symptom severity decreases, and positive when symptom severity increases. The percentage of symptoms remaining at Day 3 was calculated for each participant as the ratio of the Day 3 symptom score to the baseline score, multiplied by 100.
1 secondary outcome
secondary outcomes: • the change of each symptom (cough, sputum, fatigue), • Safety and tolerability of the intervention • Adherence to treatment • Incidence of adverse events
Time frame: The followup is conducted on Day 3, Day 5, Day 7, by phone call.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 21078173Wu S, Patel KB, Booth LJ, Metcalf JP, Lin HK, Wu W. Protective essential oil attenuates influenza virus infection: an in vitro study in MDCK cells. BMC Complement Altern Med. 2010 Nov 15;10:69. doi: 10.1186/1472-6882-10-69.
- Background: PubMed 29209859Kahler C, Derezinski T, Bocian-Sobkowska J, Keckeis A, Zacke G. Spicae aetheroleum in uncomplicated acute bronchitis: a double-blind, randomised clinical trial. Wien Med Wochenschr. 2019 Apr;169(5-6):137-148. doi: 10.1007/s10354-017-0612-0. Epub 2017 Dec 5.
- Background: PubMed 32313366Horvath G, Acs K. Essential oils in the treatment of respiratory tract diseases highlighting their role in bacterial infections and their anti-inflammatory action: a review. Flavour Fragr J. 2015 Sep;30(5):331-341. doi: 10.1002/ffj.3252. Epub 2015 May 26.
- Background: PubMed 32837899Prall S, Bowles EJ, Bennett K, Cooke CG, Agnew T, Steel A, Hausser T. Effects of essential oils on symptoms and course (duration and severity) of viral respiratory infections in humans: A rapid review. Adv Integr Med. 2020 Dec;7(4):218-221. doi: 10.1016/j.aimed.2020.07.005. Epub 2020 Aug 3.
- Background: PubMed 33212200Wani AR, Yadav K, Khursheed A, Rather MA. An updated and comprehensive review of the antiviral potential of essential oils and their chemical constituents with special focus on their mechanism of action against various influenza and coronaviruses. Microb Pathog. 2021 Mar;152:104620. doi: 10.1016/j.micpath.2020.104620. Epub 2020 Nov 16.
- Background: PubMed 31195112Tariq S, Wani S, Rasool W, Shafi K, Bhat MA, Prabhakar A, Shalla AH, Rather MA. A comprehensive review of the antibacterial, antifungal and antiviral potential of essential oils and their chemical constituents against drug-resistant microbial pathogens. Microb Pathog. 2019 Sep;134:103580. doi: 10.1016/j.micpath.2019.103580. Epub 2019 Jun 11.
- Background: PubMed 25645191Duijker G, Bertsias A, Symvoulakis EK, Moschandreas J, Malliaraki N, Derdas SP, Tsikalas GK, Katerinopoulos HE, Pirintsos SA, Sourvinos G, Castanas E, Lionis C. Reporting effectiveness of an extract of three traditional Cretan herbs on upper respiratory tract infection: results from a double-blind randomized controlled trial. J Ethnopharmacol. 2015 Apr 2;163:157-66. doi: 10.1016/j.jep.2015.01.030. Epub 2015 Jan 30.
- Background: PubMed 23447044Gillissen A, Wittig T, Ehmen M, Krezdorn HG, de Mey C. A multi-centre, randomised, double-blind, placebo-controlled clinical trial on the efficacy and tolerability of GeloMyrtol(R) forte in acute bronchitis. Drug Res (Stuttg). 2013 Jan;63(1):19-27. doi: 10.1055/s-0032-1331182. Epub 2013 Jan 8.
- Background: PubMed 32748553Rousseau G, Keijzers G, van Meer O, Craig S, Karamercan M, Klim S, Body R, Kuan WS, Harjola VP, Jones P, Verschuren F, Holdgate A, Christ M, Golea A, Capsec J, Barletta C, Graham CA, Garcia-Castrillo L, Laribi S, Kelly AM. Epidemiology, treatment and outcome of patients with lower respiratory tract infection presenting to emergency departments with dyspnoea (AANZDEM and EuroDEM studies). Emerg Med Australas. 2021 Feb;33(1):58-66. doi: 10.1111/1742-6723.13567. Epub 2020 Aug 3.
- Background: PubMed 36418965Bel Haj Ali K, Sekma A, Messous S, Trabelsi I, Ben Youssef J, Maghraoui H, Razgallah R, Walha A, Grissa MH, Beltaief K, Mezgar Z, Coubantini A, Bouida W, Msolli MA, Boukef R, Boubaker H, Nouira S. Appropriateness of antibiotic treatment of acute respiratory tract infections in Tunisian primary care and emergency departments: a multicenter cross-sectional study. BMC Prim Care. 2022 Nov 22;23(1):295. doi: 10.1186/s12875-022-01904-7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
noureddine rekik, professor, head of the departm study chair
habib bourguiba university hospial, faculty of medicine sfax university
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 essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree in people with Respiratory Inflammation, run by University of Sfax at 1 site in Tunisia.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Apr 2026. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary study endpoint was the benefits of Essential Oil in reducing symptoms (cough, sputum, fatigue). (time frame: The investigator phoned the patients on days 1, 3, 5, 7, and 10 of the ED visits to complete their follow-up. No other changes in the management were indicated.). 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 NCT07518394, which also lists 10 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 8 Apr 2026.