Patient EngagementNCT06156449
Effect of Thyme Oil on Respiratory Symptoms and Hemodynamic Parameters in COPD Patients
A study testing Thyme oil in people with Patient Engagement, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Engagement
- What is being tested?
- Thyme oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Batman Training and Research Hospital
Batman, 72070
MUSTAFA CENGİZ ZAMAN, specialist
Zeliha CENGİZ, Dr. Lecturer Member of
About this study
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.
Read the 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.
- Conditions
- Patient Engagement
- Being tested
- Thyme oil
- Keywords
- hemodynamic parameters, thyme oil, respiratory symptoms, COPD patients
- Medical subject headings
- Patient Participation, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyme oilOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention will be applied to the control group and the measurements will be recorded simultaneously. |
| experimental group | Experimental | 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. Receives: Other: Thyme oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
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.
Measured: 4 months
The pH level
Hemodynamic Parameters
Measured: 4 months
Level of O 2
Hemodynamic Parameters
Measured: 4 months
Level of CO 2
Hemodynamic Parameters
Measured: 4 months
Level of SaO 2
Hemodynamic Parameters
Measured: 4 months
pulse rate
Vital Signs Form
Measured: 4 months
respiratory rate
Vital Signs Form
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start15 Nov 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156449
- Sponsor's protocol ID
- 2023/4947
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thyme Oil on Respiratory Symptoms and Hemodynamic Parameters in COPD Patients
- ClinicalTrials.gov ID
- NCT06156449
- Acronym / sponsor ID
- 2023/4947
- Conditions
- Patient Engagement
- Keywords
- hemodynamic parameters, thyme oil, respiratory symptoms, COPD patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention will be applied to the control group and the measurements will be recorded simultaneously. |
| experimental group | Experimental | Other: Thyme oilAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- Under 18 years of age,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyme oilThe 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. | Other | experimental group |
Primary outcome
Patient Introduction Form
Time frame: 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.
COPD Symptom Form
Time frame: 4 months
This form, used by researchers with the support of the literature, consists of questions measuring the presence and severity of COPD symptoms.
The pH level
Time frame: 4 months
Hemodynamic Parameters
Level of O 2
Time frame: 4 months
Hemodynamic Parameters
Level of CO 2
Time frame: 4 months
Hemodynamic Parameters
Level of SaO 2
Time frame: 4 months
Hemodynamic Parameters
pulse rate
Time frame: 4 months
Vital Signs Form
respiratory rate
Time frame: 4 months
Vital Signs Form
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyme oil in people with Patient Engagement, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeliha Cengiz, Associate Professor (904223410220 ext. 3856, zeliha.cengiz@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Introduction Form (time frame: 4 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.