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AsthmaNCT06664671

The Effect of Thyme Oil in Asthmatic Patients

A study testing Experimental in people with Asthma and Asthma Patients, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a pre-test post-test randomized controlled trial aimed at examining the effects of thyme oil inhalation on asthma control and respiratory parameters in patients with asthma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma, Asthma Patients
What is being tested?
Experimental
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2024to 20 May 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - Patients admitted to the pulmonology ward with a diagnosis of asthma and expected to stay for at least 4 days,
  • Patients admitted on their first day in the pulmonology ward,
  • Age 18 or older,
  • Alert and conscious,
  • Open to communication and cooperation,
  • Willing to participate in the study.

Who cannot join

  • - Patients under 18 years of age,
  • Patients with pregnancy,
  • Patients with dementia and/or other organic mental disorders,
  • Patients with any psychiatric diagnosis, and
  • Patients who do not wish to participate in the study will be excluded.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • A patient in eastern Turkey

    Batman

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Thyme Oil on Asthma Control and Respiratory Parameters in Asthmatic Patients

This study is a pre-test post-test randomized controlled trial aimed at examining the effects of thyme oil inhalation on asthma control and respiratory parameters in patients with asthma. It will be conducted with 150 patients (intervention group = 50, placebo group = 50, control group = 50) in the pulmonary ward of a Training and Research Hospital in eastern Turkey. Patients will use either thyme oil-infused or placebo inhaler sticks, inhaling for eight breaths, three times a day for four days. The placebo group will receive an empty inhaler stick, while no intervention will be applied to the control group. Data will be collected from November 2024 to February 2025. The effects of thyme oil will be measured using the Asthma Control Test, Asthma Symptom and Respiratory Parameters Form, FEV1 (Forced Expiratory Volume in 1 second), and FEV1/FVC (Forced Expiratory Volume in 1 second to Forced Vital Capacity ratio) (Modified Tiffeneau-Pinelli index) values.

Hypothesis: It is hypothesized that thyme oil inhalation will significantly improve respiratory function parameters and asthma control levels in patients with asthma.

Read the detailed description

Aim of the Study This study aims to determine the effects of thyme oil on asthma control and respiratory parameters in patients with asthma.

Type of Study This study is a pre-test post-test randomized controlled experimental design.

Population The population comprises inpatients (N = 210) in the pulmonary ward of a Training and Research Hospital located in eastern Turkey. Based on a 95% confidence interval, 5% margin of error, and 95% power analysis, a minimum of 137 patients is required. To minimize attrition, the study aims to include 150 patients (intervention group = 50, placebo group = 50, control group = 50). Data will be collected between November 2024 and February 2025.

Intervention In this study, thyme oil aromatherapy will be applied via inhalation. The product used, with NV-2016 code, contains Nature\&Nurture thyme essential oil (10 µL) macra (Barcode No: 8697742121135, Registration No: 381751) and includes components such as 1,3 y-Terpinene, 2.7% p-Cymene, 5.6% linalool, 1.2% terpinen-4-ol, 1.2% borneol, 1.2% β-Bisabolene, 3.2% tymol, and 75.7% carvacrol. The thyme oil will be applied via an inhaler stick with patients instructed to inhale eight breaths, three times daily for four days.

Data Collection Tools Data will be collected using the "Patient Introduction Form," "Asthma Control Test," and "Asthma Symptom and Respiratory Parameters Form."

  • Patient Introduction Form: Created by researchers, this form includes 12 questions regarding age, weight, height, gender, marital status, education, employment, income, occupation, family asthma history, smoking, chronic illness, and asthma diagnosis duration.
  • Asthma Control Test (ACT): Developed by Nathan et al and validated by Schatz et al, the ACT is suitable for assessing asthma in patients aged 12 years and older. The test includes five questions scored on a five-point Likert scale, assessing daytime and nighttime symptoms, rescue medication usage, and impact on daily activities over the past four weeks. Scores range from 5 to 25, with higher scores indicating better asthma control. ACT reliability in Turkish (Cronbach's alpha = 0.84) was established by Uysal et al.
  • Asthma Symptom and Respiratory Parameters Form: This form was designed by researchers to assess symptoms (e.g., dyspnea, cough, chest wheezing) and includes FEV1 and FEV1/FVC respiratory parameters.

Data Collection Procedure Data collection will occur in a Teaching and Research Hospital's pulmonary ward from November 2024 to February 2025. Patients will be randomized into intervention, placebo, or control groups.

  • Intervention Group: Patients will inhale thyme oil via inhaler sticks with instructions on proper usage, supervised by the researcher. Each patient will complete the Patient Introduction Form, Asthma Control Test, and pre-test sections of the Asthma Symptom and Respiratory Parameters Form. Measurements of FEV1 and FEV1/FVC will be recorded. On the fourth day of hospitalization, post-test data will be collected.
  • Placebo Group: Patients will receive an empty inhaler stick with usage instructions, completing the same pre- and post-test procedures as the intervention group.
  • Control Group: Patients will complete pre- and post-test forms without any intervention.

Data Analysis Data analysis will be conducted using SPSS. Shapiro-Wilk Test will assess normality. Significance is set at p < 0.05. If variables are normally distributed (p > 0.05), parametric tests will be applied. Chi-square analysis will be used for categorical data. Paired t-tests will assess within-group differences, while repeated-measures ANOVA will test differences across groups, with variance homogeneity and multivariate normality checks.

Ethics Ethical approval for the study was obtained from the Inonu University Clinical Research Ethics Committee, and institutional permission was granted by Batman Training and Research Hospital. The protocol follows the Helsinki Declaration, and all participants will be informed about data confidentiality, their right to withdraw, and that no charges or costs will be incurred.

Research Hypotheses

The following hypotheses will be tested regarding the effects of thyme oil:

  • H1: Thyme oil is effective in alleviating or reducing the severity of asthma symptoms in patients with asthma.
  • H2: Thyme oil improves respiratory parameters in patients with asthma.
  • H3: Thyme oil enhances asthma control in patients with asthma.
Being tested
Experimental, Placebo, Control (Standard treatment)
Keywords
Asthma, thyme oil, Phytotherapy, Inspiration, Respiratory
Medical subject headings
Asthma, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExperimentalOther

    Patients will inhale thyme oil via inhaler sticks with instructions on proper usage, supervised by the researcher. Each patient will complete the Patient Introduction Form, Asthma Control Test, and pre-test sections of the Asthma Symptom and Respiratory Parameters Form. Measurements of FEV1 and FEV1/FVC will be recorded. On the fourth day of hospitalization, post-test data will be collected.

  • PlaceboOther

    Patients will receive an empty inhaler stick with usage instructions, completing the same pre- and post-test procedures as the intervention group.

  • Control (Standard treatment)Other

    Patients will complete pre- and post-test forms without any intervention.

Study groups in NCT06664671
Study groupRoleWhat they receive
Intervention GroupExperimentalThe product used, with NV-2016 code, contains Nature\&Nurture thyme essential oil (10 µL) macra (Barcode No: 8697742121135, Registration No: 381751) and includes components such as 1,3 y-Terpinene, 2.7% p-Cymene, 5.6% linalool, 1.2% terpinen-4-ol, 1.2% borneol, 1.2% β-Bisabolene, 3.2% tymol, and 75.7% carvacrol. The thyme oil will be applied via an inhaler stick with patients instructed to inhale eight breaths, three times daily for four days.
Receives: Other: Experimental
Placebo GroupPlacebo comparatorPatients will receive an empty inhaler stick with usage instructions, completing the same pre- and post-test procedures as the intervention group.
Receives: Other: Placebo
ControlOtherPatients will complete pre- and post-test forms without any intervention.
Receives: Other: Control (Standard treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma symptoms

    Thyme oil effectively alleviates or reduces the severity of asthma symptoms in patients with asthma. Its influence on asthma symptoms is assessed through indicators such as shortness of breath, cough, nocturnal wheezing, chest wheezing, and secretions. The presence of these symptoms and their severity levels are determined using a 10 cm horizontal line scale, with one end labeled "None" and the other end labeled "Severe." This scale serves as a measurement criterion for the outcomes obtained from the study.

    Measured: From enrollment to the end of treatment at 4 days

  2. Respiratory parameters

    Thyme oil improves respiratory parameters in patients with asthma. Its influence on respiratory parameters is assessed using indicators such as FEV1/FVC and FEV1. These respiratory parameters are recorded in the asthma symptom form.

    Measured: From enrollment to the end of treatment at 4 days

  3. Asthma control

    Thyme oil enhances asthma control in patients with asthma, as measured by symptoms such as wheezing, coughing, shortness of breath, chest tightness or pain, frequency of nebulizer medication use, and interference with work. The maximum score for this assessment is 25, while the minimum is 5. The Asthma Control Test (ACT) scoring is categorized as follows: a score of 25 indicates "complete control," scores between 20-24 indicate "good control," and scores below 19 are classified as "uncontrolled." A higher score reflects better asthma control, whereas scores of 19 or below indicate that the condition is not well-managed, necessitating adjustments in treatment to achieve better control.

    Measured: From enrollment to the end of treatment at 4 days

  4. Respiratory parameters

    Thyme oil improves respiratory parameters in patients with asthma.

    Measured: From enrollment to the end of treatment at 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start1 Nov 2024
  3. Primary completion25 Feb 2025
  4. Study completion20 May 2025

Resources

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
Experimental
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06664671
Sponsor's protocol ID
2024/126
Status last verified
Sep 2025
First submitted
25 Oct 2024
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: At the end of the study, the data of the research will be shared in international journals using English language.

Publications

  • Uysal MA, Mungan D, Yorgancioglu A, Yildiz F, Akgun M, Gemicioglu B, Turktas H; Turkish Asthma Control Test (TACT) Study Group. The validation of the Turkish version of Asthma Control Test. Qual Life Res. 2013 Sep;22(7):1773-9. doi: 10.1007/s11136-012-0309-1. Epub 2012 Nov 10.

    PubMed 23143589
  • Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.

    PubMed 14713908
  • Alavinezhad A, Hedayati M, Boskabady MH. The effect of Zataria multiflora and carvacrol on wheezing, FEV1 and plasma levels of nitrite in asthmatic patients. Avicenna J Phytomed. 2017 Nov-Dec;7(6):531-541.

    PubMed 29299436

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Asthma and Asthma Patients, 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 16 Sep 2025. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma symptoms (time frame: From enrollment to the end of treatment at 4 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06664671, which also lists 3 linked publications.

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 16 Sep 2025.

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