Effect of Thyme Oil on Respiratory Symptoms and Hemodynamic Parameters in COPD Patients

NCT06156449 | Unknown

• 1 other identifier: 2023/4947
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a high-prevalence, preventable and treatable disease characterized by abnormal respiratory symptoms and airway obstruction, often resulting from exposure to hazardous substances due to airway and/or alveolar abnormalities. The disease is an important problem with high morbidity and mortality rates all over the world and in our country. COPD is known as the third disease with a high mortality rate and the sixth disabling disease worldwide. The Global Burden of Disease Study reports 251 million cases of COPD worldwide in 2016. According to World Health Organization (WHO) data, it is estimated that 3.17 million deaths were caused by COPD in 2015. This number constitutes 5% of all deaths. More than 90% of these deaths occur in low- and middle-income countries.It has become common to use medicinal plants together with medical antiviral treatments to reduce the negative effects of COPD. Pulmonary elimination of thymol has been reported to have beneficial effects on respiratory diseases. Our research is the first to investigate in detail the effects of thyme oil on the symptoms and hemodynamic parameters of COPD. The widespread use of the thyme plant among patients shows that the research is important because it is an easily accessible, cheap and reliable essential oil.

Conditions

Patient Engagement

Keywords

hemodynamic parameters; thyme oil; respiratory symptoms; COPD patients

Outcome Measures

Primary Outcomes (8)

• Patient Introduction Form

  This form, prepared by the researchers, consists of 13 questions about age, weight, gender, marital status, education status, employment status, income status, occupation and COPD characteristic.

  4 months

• COPD Symptom Form

  This form, used by researchers with the support of the literature, consists of questions measuring the presence and severity of COPD symptoms.

  4 months

• The pH level

  Hemodynamic Parameters

  4 months

• Level of O 2

  Hemodynamic Parameters

  4 months

• Level of CO 2

  Hemodynamic Parameters

  4 months

• Level of SaO 2

  Hemodynamic Parameters

  4 months

• pulse rate

  Vital Signs Form

  4 months

• respiratory rate

  Vital Signs Form

  4 months

Study Arms (2)

Control Group

NO INTERVENTION

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

experimental 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 COPD symptom 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 OTHER

The composition of NV-2016 Coded Thyme Essential oil (Origanum vulgare) (GC-201900528) was obtained with Nature\&Nurture (10 µL) macra (Barcode No: 8697742121135, Registration No: 381751). Content of origanum vulgare oil used: 1.3% y-Terpinene, 2.7% p-Cymene, 5.6% linalool, 1.2% terpinen-4-ol, 1.2 borneol, 1.2% β-Bisabolene Contains 3.2% tymol and 75.7% carvacrol.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized with the diagnosis of COPD in the chest diseases service of a Training and Research Hospital located in the east of Turkey,
• Receiving the patient on the first day of admission to the chest diseases service (Day 1).
• Those who have been hospitalized in the chest diseases service for at least 3 days,
• Over 18 years of age,
• Being conscious,
• Open to communication and cooperation,
• Patients who volunteer to participate in the study will be included in the study.

You may not qualify if:

• Under 18 years of age,
• Those with dementia and/or other organic mental disorders,
• Those with mental retardation detected by clinical interview,
• Those who have received any psychiatric diagnosis,
• Those who are pregnant,
• Those who do not want to participate in the research,
• Patients transferred to intensive care or discharged will be excluded from the study.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Batman Training and Research Hospital

Batman, 72070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Patient Participation; Signs and Symptoms, Respiratory

Interventions

thyme oil

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zeliha Cengiz, Associate Professor

CONTACT

904223410220; zeliha.cengiz@inonu.edu.tr

Ugur Oner, lecturer doctor

CONTACT

904884449072; tuncay_126@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 5, 2023
• Study Start: November 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 15, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)