NCT05197569

Brief Summary

Coronavirus, which is a common infectious disease, is characterized by symptoms such as severe pain, cough, shortness of breath, dizziness, secretion, diarrhea, nausea-vomiting, weakness, runny nose, changes in sense of taste and smell, and loss of appetite. The use of thyme is common for this disease whose standard treatment is still being discussed. However, studies investigating the effectiveness of oregano oil are limited. These few studies in the literature have focused especially on the effects of thyme oil on Covid-19 symptoms. This work; It will be done to evaluate the effect of aromatherapy with thyme oil on Covid-19 symptoms, vital signs and hemodynamic parameters in Covid-19 patients. There is no study in the literature investigating the effects of all these variables.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

January 3, 2022

Last Update Submit

November 14, 2023

Conditions

Keywords

CoronavirusCovid-19Aromatherapythyme oilThymus vulgaris

Outcome Measures

Primary Outcomes (5)

  • Demographic Characteristics Form

    This form, created by the researchers, consists of 10 questions in total, questioning the characteristics of diagnosis, weight, gender, chronic disease status and Covid-19 .

    6 months

  • Covid-19 Symptom Form

    This form, which was created by the researchers with the support of the literature, consists of 13 questions that include evaluations that measure the patient's Covid-19 symptoms and the level of severity.

    6 months

  • Hemodynamic parameters form

    From the blood gas values of this form created by the researcher; It was created to record the pH, O 2 , CO 2 , SaO 2 measurement results.

    6 months

  • Visual Comparison Scale

    This scale is the most widely used scale for pain assessment. In this study, it will be used for the evaluation of muscle-joint pain and headache, which are the symptoms of Covid-19. Usually 10 cm long, horizontally or vertically; It is the line from "No Pain" (0 point) to "Severe Pain" (10 points). As the score on the visual comparison scale increases, the severity of the disease increases. This line can be straight or vertical. It may include words or numbers used to describe pain, written on evenly spaced lines. It is generally accepted that the horizontal line is easier to understand.

    6 months

  • Vital signs follow-up form

    Vital signs follow-up form was created to record the patient's daily fever, pulse, respiratory rate, systolic diastolic blood pressure values.

    6 months

Study Arms (2)

Control group

NO INTERVENTION

No intervention will be applied to the control group and the measurements will be recorded simultaneously.

Thyme oil group

EXPERIMENTAL

After filling out the forms, thyme oil aromatherapy will be applied to the patients assigned to the experimental group .The oregano oil to be prepared must have a high carvacrol ratio. Thyme oil with a carvacrol ratio of at least 74% will be specific to each patient and will be given to the patient in the form of an inhaler stick. According to expert opinion; The patient's own room should be visited every 8 hours and the patient-specific inhaler stick should be sniffed into 8 breathing lungs. Each patient will use an inhaler stick for 5 days. Hemodynamic parameters (ph, CO 2, O 2 ) and Covid-19 symptoms will be measured before the intervention with the patient (pretest) and at the end of the 5th day (posttest). Vital signs will be measured and recorded three times a day in the patient's room at 08:00, 16:00 and 24:00.

Other: thyme oil

Interventions

Thyme oil with a carvacrol ratio of at least 74% will be specific to each patient and will be given to the patient in the form of an inhaler stick. According to expert opinion; The patient's own room should be visited every 8 hours and the patient-specific inhaler stick should be sniffed into 8 breathing lungs. Each patient will use an inhaler stick for 5 days. Hemodynamic parameters (ph, CO 2, O 2 ) and Covid-19 symptoms will be measured before the intervention with the patient (pretest) and at the end of the 5th day (posttest). Vital signs will be measured and recorded three times a day in the patient's room at 08:00, 16:00 and 24:00.

Thyme oil group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PCR test positive
  • Being in the covid-19 service
  • Involvement in the lung as a result of computed tomography between 50-80% to be
  • The day of admission to the Covid 19 service (1. Day) sickareceipt of

You may not qualify if:

  • Having a pregnancy status
  • be under the age of 18
  • unwillingness to participate in the study
  • Patients who will be transferred to the intensive care unit will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman Training and Research Hospital

Batman, 72070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient ParticipationCoronavirus InfectionsCOVID-19

Interventions

thyme oil

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In the study, patients will be stratified according to their gender (male and female) status and the blocking process will be performed. In this study, block randomization will be done according to age groups in order to assign the participants to the experimental and control groups. Patients will be listed according to the hospitalization list and numbered up to 140. Numbers will be assigned to the experimental and control groups according to the random numbers list. Thus, the probability of each patient in the groups being in either of the intervention or control groups will be equalized. Group 1: experimental 2. Group: Control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 19, 2022

Study Start

January 31, 2022

Primary Completion

February 14, 2023

Study Completion

February 14, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

This research is a doctoral thesis study. The research is expected to be completed.

Locations