Oral Essential Oils Efficacy in Acute Respiratory Symptoms

NCT07518394 | Completed Phase 4

• 1 other identifier: USfax
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Respiratory Inflammation

Keywords

Essential Oil; Dietary Supplement; Low Tract Respiratory Infection; Symptom Management; Respiratory Complaints; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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.

  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 followup is conducted on Day 3, Day 5, Day 7, by phone call.

Study Arms (2)

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

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

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

Interventions

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.

Essential oil group

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sfax: lead

Study Sites (1)

Habib Bourguiba University Hospital, Sfax

Sfax, Sfax Governorate, 3029, Tunisia

Location

Related Publications (10)

• 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.

  PMID: 21078173 BACKGROUND

• Kahler 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.

  PMID: 29209859 BACKGROUND

• Horvath 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.

  PMID: 32313366 BACKGROUND

• Prall 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.

  PMID: 32837899 BACKGROUND

• Wani 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.

  PMID: 33212200 BACKGROUND

• Tariq 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.

  PMID: 31195112 BACKGROUND

• Duijker 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.

  PMID: 25645191 BACKGROUND

• Gillissen 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.

  PMID: 23447044 BACKGROUND

• Rousseau 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.

  PMID: 32748553 BACKGROUND

• Bel 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.

  PMID: 36418965 BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• noureddine rekik, professor, head of the departm

  habib bourguiba university hospial, faculty of medicine sfax university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: April 8, 2026
• Study Start: March 1, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 30, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)