The Effect of Thyme Oil in Asthmatic Patients

NCT06664671 | Completed

• 1 other identifier: 2024/126
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asthma; Asthma Patients

Keywords

Asthma; thyme oil; Phytotherapy; Inspiration; Respiratory

Outcome Measures

Primary Outcomes (4)

• 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.

  From enrollment to the end of treatment at 4 days

• 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.

  From enrollment to the end of treatment at 4 days

• 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.

  From enrollment to the end of treatment at 4 days

• Respiratory parameters

  Thyme oil improves respiratory parameters in patients with asthma.

  From enrollment to the end of treatment at 4 days

Study Arms (3)

Intervention Group

EXPERIMENTAL

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.

Other: Experimental

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Control

OTHER

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

Other: Control (Standard treatment)

Interventions

Experimental OTHER

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.

Intervention Group

Placebo OTHER

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

Placebo Group

Control (Standard treatment) OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

A patient in eastern Turkey

Batman, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 29299436 BACKGROUND

• 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.

  PMID: 23143589 BACKGROUND

• 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.

  PMID: 14713908 BACKGROUND

MeSH Terms

Conditions

Asthma; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion: February 25, 2025
• Study Completion: May 20, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TU (1)