Clinical trial NCT06156449: Effect of Thyme Oil on Respiratory Symptoms and Hemodynamic Parameters in COPD Patients
Official title: Effect of Thyme Oil on Respiratory Symptoms and Hemodynamic Parameters in COPD Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Engagement
Keywords: hemodynamic parameters
thyme oil
respiratory symptoms
COPD patients
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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: Control
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Introduction Form
timeFrame: 4 months
measure: COPD Symptom Form
timeFrame: 4 months
measure: The pH level
timeFrame: 4 months
measure: Level of O 2
timeFrame: 4 months
measure: Level of CO 2
timeFrame: 4 months
measure: Level of SaO 2
timeFrame: 4 months
measure: pulse rate
timeFrame: 4 months
measure: respiratory rate
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman Training and Research Hospital
Study officials:
References: