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Completed

NCT Number: NCT07518394

Oral Essential Oils Efficacy in Acute Respiratory Symptoms

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

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Key information

Conditions

Respiratory Inflammation Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Habib Bourguiba University Hospital, Sfax

Sfax, Sfax Governorate, 3029, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

essential oils of eucalyptus, thyme, cinnamon, lavender, winter savory, tea tree, camphor tree

Dietary 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 capsule

Dietary Supplement

the placebo capsule were identical in color, taste, smell, consistency, and packaging and do not contains essential oils.

Primary outcomes

  1. 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.

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

    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.

Sponsors and collaborators

Lead sponsor

University of Sfax

Other

Registry information

Official study title

Using Botanical Ingestible Oils for Treating Infectious Conditions: The UBIOTIC Study on Essential Oils for Lower Respiratory Infections in the Emergency Department

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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