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