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

Titin Andri Wihastuti

Status: Completed

Conditions: Cigarette Smoking; Psychological Stress; Tobacco Use Disorder; Nicotine Dependence; Sleep Disturbance

Treatments: Other: Lemongrass Inhaler; Other: Lemongrass Liquid Vapor; Other: Lemongrass Inhaler and Liquid Vapor

Study type: Interventional

Funder types: Other

Identifiers

NCT07366294

00147.3/UN10.A0501/B/PT01.03.2 (Other Identifier)

00147.3/UN10.A0501/B/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Control

No Intervention group

Description:

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

Experimental group

Description:

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

Treatment:

Other: Lemongrass Inhaler

Lemongrass Liquid Vapor

Experimental group

Description:

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

Treatment:

Other: Lemongrass Liquid Vapor

Lemongrass Inhaler and Liquid Vapor

Experimental group

Description:

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

Treatment:

Other: Lemongrass Inhaler and Liquid Vapor