Oral Essential Oils Efficacy in Acute Respiratory Symptoms

April 6, 2026 updated by: Olfa Chakroun-Walha, University of Sfax

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Sfax Governorate
      • Sfax, Sfax Governorate, Tunisia, 3029
        • Habib Bourguiba University Hospital, Sfax

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-communicating patients
  • Pregnant patients
  • Patients with known allergy to study components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
this group will be invited to take a placebo capsule in addition to the standard treatment prescribed at discharge from the emergency department
Dietary supplement: placebo of the essential oil capsule
the placebo capsule were identical in color, taste, smell, consistency, and packaging and do not contains essential oils.
Active Comparator: Essential oil group
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
Dietary supplement: essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
The followup is conducted on Day 3, Day 5, Day 7, by phone call.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sfax

Investigators

  • Study Chair: noureddine rekik, professor, head of the departm, habib bourguiba university hospial, faculty of medicine sfax university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USfax

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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