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

Patient Engagement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156449
• Other study ID #: 2023/4947
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: December 2023
• Source: Inonu University
• Contact: Zeliha Cengiz, Associate Professor
• Phone: 904223410220
• Email: zeliha.cengiz[@]inonu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Engagement
• Signs and Symptoms, Respiratory

Intervention

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% ß-Bisabolene Contains 3.2% tymol and 75.7% carvacrol.

Locations

Country	Name	City	State
Turkey	Batman Training and Research Hospital	Batman

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The pH level	Hemodynamic Parameters	4 months
Primary	Level of O 2	Hemodynamic Parameters	4 months
Primary	Level of CO 2	Hemodynamic Parameters	4 months
Primary	Level of SaO 2	Hemodynamic Parameters	4 months
Primary	pulse rate	Vital Signs Form	4 months
Primary	respiratory rate	Vital Signs Form	4 months