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

Sponsor
Inonu University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06156449
Collaborator
(none)
120
1
2
5
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Thyme oil
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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: ControlIn 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
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effect of Thyme Oil on Respiratory Symptoms and Hemodynamic Parameters in COPD Patients
Actual Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Apr 15, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

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

Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Patient Introduction Form [4 months]

    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.

  2. COPD Symptom Form [4 months]

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

  3. The pH level [4 months]

    Hemodynamic Parameters

  4. Level of O 2 [4 months]

    Hemodynamic Parameters

  5. Level of CO 2 [4 months]

    Hemodynamic Parameters

  6. Level of SaO 2 [4 months]

    Hemodynamic Parameters

  7. pulse rate [4 months]

    Vital Signs Form

  8. respiratory rate [4 months]

    Vital Signs Form

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Batman Training and Research Hospital Batman Turkey 72070

Sponsors and Collaborators

  • Inonu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeliha CENGİZ, Associate Professor, Inonu University
ClinicalTrials.gov Identifier:
NCT06156449
Other Study ID Numbers:
  • 2023/4947
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Dec 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeliha CENGİZ, Associate Professor, Inonu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023