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NCT Number: NCT07366294

Lemongrass (Cymbopogon Citratus) on Nicotine Dependence, Cotinine Levels, and Related Biomarkers in Adult Smokers

The goal of this clinical trial is to learn whether lemongrass (Cymbopogon citratus) inhaler and liquid vapor interventions affect nicotine dependence and related biological and behavioral outcomes in adult smokers. The study will also evaluate changes in blood biomarkers, psychological well-being, and lifestyle-related measures. The main questions it aims to answer are:

* Do lemongrass inhalers and/or liquid vapor reduce nicotine dependence and cotinine levels in adult smokers? * How do these interventions affect blood lipid profile and biomarkers of inflammation, oxidative stress, endothelial function, and stress response, including interleukin-6 (IL-6), malondialdehyde (MDA), superoxide dismutase (SOD), nitric oxide (NO), cortisol, and nicotinic acetylcholine receptors (nAChRs)? * Do lemongrass inhaler and liquid vapor influence appetite, physical fitness, sleep quality, and psychological status measured using the Depression, Anxiety, and Stress Scale (DASS)?

Researchers will compare participants receiving lemongrass inhaler, lemongrass liquid vapor, or a combination of both to a control group receiving no intervention to evaluate the effects of the interventions.

Participants will:

* Receive a lemongrass inhaler, lemongrass liquid vapor, a combination of both, or no intervention according to group assignment * Continue their usual daily activities during the study period * Provide blood samples and complete questionnaires to assess biochemical markers, nicotine dependence, appetite, fitness level, sleep quality, and psychological status

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Key information

Conditions

Nicotine Dependence Behavior Behavioral Symptoms Chemically-Induced Disorders Cigarette Smoking Mental Disorders Nervous System Diseases Parasomnias Psychological Stress Sleep Disturbance Sleep Wake Disorders Smoking Stress, Psychological Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Brawijaya

Malang, East Java, 65145, Indonesia

About this study

Cigarette smoking is associated with nicotine dependence and a wide range of biological, psychological, and lifestyle-related alterations, including oxidative stress, inflammation, neuroendocrine dysregulation, and impaired functional well-being. Complementary inhalation-based approaches using plant-derived aromatic compounds may offer supportive benefits by modulating smoking-related biological and behavioral responses.

This open-label, parallel-group interventional study is conducted to evaluate the effects of lemongrass (Cymbopogon citratus)-based inhaler and liquid vapor formulations in adult smokers. Participants are assigned to receive a lemongrass inhaler, lemongrass liquid vapor, a combination of both interventions, or no intervention. The study is designed to compare intervention groups with a non-intervention control group under real-world conditions.

The lemongrass inhaler and vapor products are formulated to provide consistent aromatic exposure and have undergone standardized physical, organoleptic, and stability evaluations prior to use. Interventions are administered according to predefined study procedures.

The study assesses biological, behavioral, and functional responses related to smoking exposure and dependence, including biochemical, neuroendocrine, and psychosocial domains. Data are collected using standardized laboratory methods and validated assessment tools.

By integrating objective biomarkers with behavioral and functional measures, this study aims to provide insight into the potential role of lemongrass-based inhalation interventions as supportive strategies for addressing smoking-related health effects in adult smokers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 30 years
  • Current cigarette smokers reporting consumption of ≥5 cigarettes per day
  • Moderate to high nicotine dependence, defined as a Fagerström Test for Nicotine Dependence (FTND) score≥5
  • Members of the academic community of the Faculty of Health Sciences, Universitas Brawijaya, Malang, East Java, Indonesia
  • Willing and able to provide informed consent and comply with study procedures

Exclusion criteria

  • Current use of smoking cessation medications
  • History of lemongrass allergy
  • Presence of chronic respiratory conditions
  • History of severe cardiovascular disease
  • History of severe psychiatric disorders
  • Pregnancy

Treatment and study plan

Lemongrass Inhaler

Other

Participants receive a lemongrass (Cymbopogon citratus) inhaler administered by inhalation according to the study protocol.

Lemongrass Liquid Vapor

Other

Participants receive lemongrass (Cymbopogon citratus) liquid vapor administered via vaporization according to the study protocol.

Lemongrass Inhaler and Liquid Vapor

Other

Participants receive a combination of lemongrass (Cymbopogon citratus) inhaler and liquid vapor administered concurrently according to the study protocol.

Primary outcomes

  1. Change in Nicotine Dependence (FTND Score)

    Time frame: Baseline up to 4 weeks

    Change in nicotine dependence measured using the Fagerström Test for Nicotine Dependence (FTND), a validated 6-item questionnaire with total scores ranging from 0 to 10, where higher scores indicate greater nicotine dependence.

Secondary outcomes

  1. Change in Cotinine Levels

    Time frame: Baseline up to 4 weeks

    Change in blood cotinine concentration measured using enzyme-linked immunosorbent assay (ELISA), reported in nanograms per milliliter (ng/mL).

  2. Change in Lipid Profile

    Time frame: Baseline up to 4 weeks

    Change in blood lipid profile parameters, including total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides, measured using standard enzymatic laboratory methods and reported in milligrams per deciliter (mg/dL).

  3. Change in Inflammatory and Oxidative Stress Biomarkers

    Time frame: Baseline up to 4 weeks

    Change in interleukin-6 concentration measured using ELISA and reported in picograms per milliliter (pg/mL), malondialdehyde concentration reported in nanomoles per milliliter (nmol/mL), superoxide dismutase activity reported in units per milliliter (U/mL), and nitric oxide concentration reported in micromoles per liter (µmol/L).

  4. Change in Neuroendocrine and Receptor-Related Biomarkers

    Time frame: Baseline up to 4 weeks

    Change in cortisol concentration measured using ELISA and reported in micrograms per deciliter (µg/dL), and nicotinic acetylcholine receptor-related measures assessed using laboratory-based immunoassays and reported in relative expression units.

  5. Change in Appetite

    Time frame: Baseline up to 4 weeks

    Change in appetite assessed using a standardized appetite questionnaire, reported as a total score ranging from 0 to 10, where higher scores indicate greater appetite.

  6. Change in Sleep Quality

    Time frame: Baseline up to 4 weeks

    Change in sleep quality assessed using a validated sleep questionnaire, reported as a total score ranging from 0 to 10, where higher scores indicate poorer sleep quality.

  7. Change in Psychological Status

    Time frame: Baseline up to 4 weeks

    The Depression, Anxiety, and Stress Scale (DASS) consists of three subscales with score ranges of 0-42 for each subscale, where higher scores indicate greater severity of symptoms.

Sponsors and collaborators

Lead sponsor

Titin Andri Wihastuti

Other

Collaborators

  • University of Brawijaya

Registry information

Official study title

Effects of Lemongrass (Cymbopogon Citratus) on Nicotine Dependence, Cotinine Levels, and Related Biomarkers in Adult Smokers

Acronym: CCIVS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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