Effects of Lemongrass (Cymbopogon Citratus) on Nicotine Dependence, Cotinine Levels, and Related Biomarkers in Adult Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Nicotine Dependence (FTND Score)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Participants in this arm do not receive lemongrass inhaler or liquid vapor. They continue their usual smoking behavior and daily activities without any additional intervention for the duration of the study.
Lemongrass Inhaler
Participants receive a lemongrass (Cymbopogon citratus) inhaler administered by inhalation according to the study protocol.
干预措施: Lemongrass Inhaler (Other)
Lemongrass Liquid Vapor
Participants receive lemongrass (Cymbopogon citratus) liquid vapor administered via vaporization according to the study protocol.
干预措施: Lemongrass Liquid Vapor (Other)
Lemongrass Inhaler and Liquid Vapor
Participants receive a combination of lemongrass (Cymbopogon citratus) inhaler and liquid vapor administered concurrently according to the study protocol.
干预措施: Lemongrass Inhaler and Liquid Vapor (Other)
结局指标
主要结局
Change in Nicotine Dependence (FTND Score)
时间窗: 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.
次要结局
- Change in Cotinine Levels(Baseline up to 4 weeks)
- Change in Lipid Profile(Baseline up to 4 weeks)
- Change in Inflammatory and Oxidative Stress Biomarkers(Baseline up to 4 weeks)
- Change in Neuroendocrine and Receptor-Related Biomarkers(Baseline up to 4 weeks)
- Change in Appetite(Baseline up to 4 weeks)
- Change in Sleep Quality(Baseline up to 4 weeks)
- Change in Psychological Status(Baseline up to 4 weeks)
研究者
Titin Andri Wihastuti
Principal Investigator (Professor)
University of Brawijaya