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

NCT07366294 | Completed DMC

• 2 other identifiers: 00147.3/UN10.A0501/B/202400147.3/UN10.A0501/B/PT01.03.2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Cymbopogon citratus; Nicotine Dependence; Smoking Biomarkers; Oxidative Stress; Adult Smokers

Outcome Measures

Primary Outcomes (1)

• Change in Nicotine Dependence (FTND Score)

  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.

  Baseline up to 4 weeks

Secondary Outcomes (7)

• 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

Study Arms (4)

Control

NO INTERVENTION

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

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

Other: Lemongrass Inhaler

Lemongrass Liquid Vapor

EXPERIMENTAL

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

Other: Lemongrass Liquid Vapor

Lemongrass Inhaler and Liquid Vapor

EXPERIMENTAL

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

Other: Lemongrass Inhaler and Liquid Vapor

Interventions

Lemongrass Inhaler OTHER

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

Lemongrass Inhaler

Lemongrass Liquid Vapor OTHER

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

Lemongrass Liquid Vapor

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.

Lemongrass Inhaler and Liquid Vapor

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Titin Andri Wihastuti: lead
• University of Brawijaya: collaborator

Study Sites (1)

University of Brawijaya

Malang, East Java, 65145, Indonesia

Location

Related Publications (3)

• Moreira da Silva TL, Beltrame FL, Ferrari PC. Lemongrass essential oil micro- and nanoencapsulation for industrial application: Production techniques and potential applications. Arch Pharm (Weinheim). 2024 Jun;357(6):e2300726. doi: 10.1002/ardp.202300726. Epub 2024 Mar 28.

  PMID: 38548681 BACKGROUND

• Adhikary K, Banerjee P, Barman S, Bandyopadhyay B, Bagchi D. Nutritional Aspects, Chemistry Profile, Extraction Techniques of Lemongrass Essential Oil and It's Physiological Benefits. J Am Nutr Assoc. 2024 Feb;43(2):183-200. doi: 10.1080/27697061.2023.2245435. Epub 2023 Aug 14.

  PMID: 37579058 BACKGROUND

• Rabbani A, Khaliq A, Mudgil P, Maqsood S, Nazir A. Recent Advances in Lemongrass Essential Oil: Food Safety, Preservation, and Bioactivity in Food Systems. Compr Rev Food Sci Food Saf. 2026 Jan;25(1):e70350. doi: 10.1111/1541-4337.70350.

  PMID: 41347276 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Stress, Psychological; Parasomnias

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Behavioral Symptoms; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Titin A Wihastuti, Professor

  Brawijaya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator (Professor)

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 26, 2026
• Study Start: October 7, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 10, 2024
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)