MedDataX Logo

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

NCT ID: NCT06156449

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic obstructive pulmonary disease is treated with pharmacological and non-pharmacological methods. The first step of disease management is pharmacological treatment. Pharmacological treatment is generally preferred to reduce the frequency, duration and severity of symptoms experienced by the patient, reduce the acute exacerbation of the disease, improve the exercise capacity of the patients and increase the quality of life. Non-pharmacological treatments are; These are practices such as physical therapy, massage, relaxation techniques, meditation, reiki, yoga, prayer, multivitamins, herbal medicines, osteopathy, cryopathy, homeopathy, acupuncture, acupressure, reflexology, music therapy, visualization, hypnosis, and suggestion.

It has become common to use medicinal plants together with medical antiviral treatments to reduce the negative effects of COPD. Among these, thyme is a plant from the Lamiaceae family that has no known significant side effects and is used for its healing effects. Thyme plant belongs to the mint family and the plant contains antioxidant compounds such as phenolic, eugenol, carvacrol and thymol. Pulmonary elimination of thymol has been reported to have beneficial effects on respiratory diseases. In the literature, Chabok et al. It has been reported that it improves gas exchange in the respiratory tract and increases oxygen saturation value. Similarly, Schönknecht et al. determined that thyme is a spasmolytic, antimicrobial, anti-inflammatory, immunomodulatory and antioxidant agent. Additionally, Oliveiro et al. reported that thyme could be an effective treatment of chronic diseases based on inflammatory processes in cases of morbidity and mortality in lung cancer patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient Engagement

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hemodynamic parameters thyme oil respiratory symptoms COPD patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

experimental group

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.

Group Type EXPERIMENTAL

Thyme oil

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thyme oil

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zeliha CENGİZ

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Batman Training and Research Hospital

Batman, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zeliha Cengiz, Associate Professor

Role: CONTACT

Phone: 904223410220

Email: [email protected]

Ugur Oner, lecturer doctor

Role: CONTACT

Phone: 904884449072

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

MUSTAFA CENGİZ ZAMAN, specialist

Role: primary

Zeliha CENGİZ, Dr. Lecturer Member of

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023/4947

Identifier Type: -

Identifier Source: org_study_id