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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06156449
Other study ID # 2023/4947
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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