Nicotine DependenceCCIVSNCT07366294
Lemongrass (Cymbopogon Citratus) on Nicotine Dependence, Cotinine Levels, and Related Biomarkers in Adult Smokers
A study testing Lemongrass Inhaler, Lemongrass Liquid Vapor and Lemongrass Inhaler and Liquid Vapor in people with Nicotine Dependence and Cigarette Smoking, run by Titin Andri Wihastuti at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarette Smoking, Tobacco Use Disorder
- What is being tested?
- Lemongrass Inhaler, Lemongrass Liquid Vapor and Lemongrass Inhaler and Liquid Vapor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Oct 2024to 10 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 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)?
Read more
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
Read the 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.
- Conditions
- Nicotine Dependence, Cigarette Smoking, Tobacco Use Disorder, Psychological Stress, Sleep Disturbance
- Being tested
- Lemongrass Inhaler, Lemongrass Liquid Vapor, Lemongrass Inhaler and Liquid Vapor
- Keywords
- Cymbopogon citratus, Nicotine Dependence, Smoking Biomarkers, Oxidative Stress, Adult Smokers
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Stress, Psychological, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemongrass InhalerOther
Participants receive a lemongrass (Cymbopogon citratus) inhaler administered by inhalation according to the study protocol.
Lemongrass Liquid VaporOther
Participants receive lemongrass (Cymbopogon citratus) liquid vapor administered via vaporization according to the study protocol.
Lemongrass Inhaler and Liquid VaporOther
Participants receive a combination of lemongrass (Cymbopogon citratus) inhaler and liquid vapor administered concurrently according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lemongrass Inhaler |
| Lemongrass Liquid Vapor | Experimental | Participants receive lemongrass (Cymbopogon citratus) liquid vapor administered via vaporization according to the study protocol. Receives: 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. Receives: Other: Lemongrass Inhaler and Liquid Vapor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 4 weeks
Secondary outcomes (7)
Change in Cotinine Levels
Change in blood cotinine concentration measured using enzyme-linked immunosorbent assay (ELISA), reported in nanograms per milliliter (ng/mL).
Measured: Baseline up to 4 weeks
Change in Lipid Profile
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).
Measured: Baseline up to 4 weeks
Change in Inflammatory and Oxidative Stress Biomarkers
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).
Measured: Baseline up to 4 weeks
Change in Neuroendocrine and Receptor-Related Biomarkers
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.
Measured: Baseline up to 4 weeks
Change in Appetite
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.
Measured: Baseline up to 4 weeks
Change in Sleep Quality
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.
Measured: Baseline up to 4 weeks
Change in Psychological Status
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.
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start7 Oct 2024
- Primary completion7 Nov 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Titin Andri Wihastuti
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brawijaya
- Responsible party
- Sponsor-investigator, Titin Andri Wihastuti, University of Brawijaya
- Investigators
- Titin A Wihastuti, Professor, Principal investigator, Brawijaya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366294
- Sponsor's protocol ID
- 00147.3/UN10.A0501/B/2024
- Other IDs
- 00147.3/UN10.A0501/B/PT01.03.2
- Acronym
- CCIVS
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to confidentiality concerns, small sample size, and the absence of participant consent and infrastructure for secure data sharing. Study findings will be reported in aggregate form.
Publications
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.
PubMed 38548681Adhikary 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.
PubMed 37579058Rabbani 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.
PubMed 41347276
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lemongrass (Cymbopogon Citratus) on Nicotine Dependence, Cotinine Levels, and Related Biomarkers in Adult Smokers
- ClinicalTrials.gov ID
- NCT07366294
- Acronym / sponsor ID
- CCIVS / 00147.3/UN10.A0501/B/2024
- Conditions
- Nicotine Dependence, Cigarette Smoking, Tobacco Use Disorder, Psychological Stress, Sleep Disturbance
- Keywords
- Cymbopogon citratus, Nicotine Dependence, Smoking Biomarkers, Oxidative Stress, Adult Smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Titin Andri WihastutiUniversity, hospital or other
- Collaborators
- University of Brawijaya
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Lemongrass InhalerParticipants receive a lemongrass (Cymbopogon citratus) inhaler administered by inhalation according to the study protocol. |
| Lemongrass Liquid Vapor | Experimental | Other: Lemongrass Liquid VaporParticipants receive lemongrass (Cymbopogon citratus) liquid vapor administered via vaporization according to the study protocol. |
| Lemongrass Inhaler and Liquid Vapor | Experimental | Other: Lemongrass Inhaler and Liquid VaporParticipants receive a combination of lemongrass (Cymbopogon citratus) inhaler and liquid vapor administered concurrently according to the study protocol. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemongrass InhalerParticipants receive a lemongrass (Cymbopogon citratus) inhaler administered by inhalation according to the study protocol. | Other | Lemongrass Inhaler |
| Lemongrass Liquid VaporParticipants receive lemongrass (Cymbopogon citratus) liquid vapor administered via vaporization according to the study protocol. | Other | Lemongrass Liquid Vapor |
| Lemongrass Inhaler and Liquid VaporParticipants receive a combination of lemongrass (Cymbopogon citratus) inhaler and liquid vapor administered concurrently according to the study protocol. | Other | Lemongrass Inhaler and Liquid Vapor |
Primary outcome
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.
7 secondary outcomes
Change in Cotinine Levels
Time frame: Baseline up to 4 weeks
Change in Lipid Profile
Time frame: Baseline up to 4 weeks
Change in Inflammatory and Oxidative Stress Biomarkers
Time frame: Baseline up to 4 weeks
Change in Neuroendocrine and Receptor-Related Biomarkers
Time frame: Baseline up to 4 weeks
Change in Appetite
Time frame: Baseline up to 4 weeks
Change in Sleep Quality
Time frame: Baseline up to 4 weeks
Change in Psychological Status
Time frame: Baseline up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 38548681Moreira 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.
- Background: PubMed 37579058Adhikary 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.
- Background: PubMed 41347276Rabbani 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.
- Individual participant dataSharing planned: No. IPD will not be shared due to confidentiality concerns, small sample size, and the absence of participant consent and infrastructure for secure data sharing. Study findings will be reported in aggregate form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Titin A Wihastuti, Professor principal investigator
Brawijaya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lemongrass Inhaler, Lemongrass Liquid Vapor and Lemongrass Inhaler and Liquid Vapor in people with Nicotine Dependence and Cigarette Smoking, run by Titin Andri Wihastuti at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nicotine Dependence (FTND Score) (time frame: Baseline up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366294, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.