Cigarette Smoking, Nicotine Dependence, Psychological Stress, Sleep Disturbance, Tobacco Use Disorder
Conditions
Keywords
Cymbopogon citratus, Nicotine Dependence, Smoking Biomarkers, Oxidative Stress, Adult Smokers
Brief summary
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
Detailed description
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.
Interventions
OTHERLemongrass Inhaler
Participants receive a lemongrass (Cymbopogon citratus) inhaler administered by inhalation according to the study protocol.
OTHERLemongrass Liquid Vapor
Participants receive lemongrass (Cymbopogon citratus) liquid vapor administered via vaporization according to the study protocol.
OTHERLemongrass Inhaler and Liquid Vapor
Participants receive a combination of lemongrass (Cymbopogon citratus) inhaler and liquid vapor administered concurrently according to the study protocol.
Sponsors
Titin Andri Wihastuti
University of Brawijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study is conducted as an open-label trial. Participants, care providers, investigators, and outcome assessors, including laboratory analysts, are aware of the assigned intervention.
Intervention model description
Participants are allocated in parallel to receive either a lemongrass (Cymbopogon citratus) inhaler and vapor intervention or a control condition, with outcomes assessed concurrently across study arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nicotine Dependence (FTND Score) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cotinine Levels | Baseline up to 4 weeks | Change in blood cotinine concentration measured using enzyme-linked immunosorbent assay (ELISA), reported in nanograms per milliliter (ng/mL). |
| Change in Lipid Profile | 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). |
| Change in Inflammatory and Oxidative Stress Biomarkers | 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). |
| Change in Neuroendocrine and Receptor-Related Biomarkers | 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. |
| Change in Appetite | 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. |
| Change in Sleep Quality | 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. |
| Change in Psychological Status | 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. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORTitin A Wihastuti, Professor
Brawijaya University
Outcome results
None listed