Depression DisorderNCT07384312
Study on the Antidepressant Effects and Mechanism of Action of Cang-ai Volatile Oil Based on Near-Infrared Functional Brain Imaging and the NT-Trk Signalling Pathway
A study testing Cang-ai Volatile Oil and Bergamot Essential Oil in people with Depression Disorder, run by Dongdong Qin at 1 site in China.
Trial summary
This project plans to recruit 60 patients with depression, randomly assigning them to either the CAVO group or the bergamot essential oil group, with 30 participants in each. Quantitative measurement will be conducted using fNIRS technology to assess the impact of the intranasal CAVO pathway on brain functional… Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Disorder
- What is being tested?
- Cang-ai Volatile Oil and Bergamot Essential Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets the diagnostic criteria for depressive episodes as outlined in the fifth edition (revised) of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Meets the diagnostic criteria for depression syndrome as defined in Part 1: Diseases of the Terminology for Clinical Diagnosis and Treatment in Traditional Chinese Medicine, issued by the National Administration of Traditional Chinese Medicine in 2023.
- Scores on the 21-item Beck Depression Inventory (BDI) range from 10 to 15; scores on the 24-item Hamilton Depression Rating Scale (HAMD) range from 8 to 20.
- Has a normal olfactory function, no history of allergic or respiratory diseases, aged 18-26 years.
- At least one week prior to assessment, has not used antidepressants, other psychotropic medications, electroconvulsive therapy, or undergone transcranial magnetic stimulation or other physical therapies.
- Exhibits depressive symptoms persisting for more than two weeks.
- Right-handed.
- Approved by the hospital ethics committee; all participants volunteer and have provided written informed consent.
Who cannot join
- Strict exclusion of individuals with a history of schizophrenia, alcohol dependence, or substance abuse.
- Presence of organic brain disease, endocrine disorders, or depression secondary to other mental illnesses.
- A score of ≥3 points on the suicidal item of the Hamilton Depression Rating Scale.
- Pregnant or lactating women, or those with a history of manic or hypomanic episodes.
- Family history of monomorphic or bipolar affective disorder.
Trial locations and contacts
1 site in 1 country.
About this study
This project plans to recruit 60 patients with depression, randomly assigning them to either the CAVO group or the bergamot essential oil group, with 30 participants in each. Quantitative measurement will be conducted using fNIRS technology to assess the impact of the intranasal CAVO pathway on brain functional connectivity during rest and brain activation during task performance. The antidepressant effects of CAVO will be evaluated using standardized depression scales, and target brain regions for CAVO's action will be identified through this process.
- Conditions
- Depression Disorder
- Being tested
- Cang-ai Volatile Oil, Bergamot Essential Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cang-ai Volatile OilDrug
The experimental group received CAVO inhalation therapy, during which one drop (0.05 ml) of 10% mugwort volatile oil was administered into the aromatherapy diffuser using a Pasteur pipette. The diffuser was secured near the participant's nose on the mask with a magnet, and subjects were instructed to continuously inhale for one hour each day.
Bergamot Essential OilDrug
The control group received BEO inhalation therapy, during which one drop (0.05 mL per drop) of 10% mandarin essential oil was administered into the aroma diffuser using a Pasteur pipette. The diffuser was secured near the participant's nose with a magnet fixed to the mask. Participants were instructed to continue smelling the aroma for 1 hour daily.
| Study group | Role | What they receive |
|---|---|---|
| CAVO group | Active comparator | The experimental group received CAVO inhalation therapy, with 0.05 ml (1 drop) of 10% Artemisia absinthium volatile oil dripped into the aroma diffusion capsule using a Pasteur pipette. The capsule was secured near the participant's nose on the mask with a magnet, and they were instructed to continue inhaling continuously for 1 hour daily. Receives: Drug: Cang-ai Volatile Oil |
| BEO Group | Active comparator | The control group received BEO inhalation therapy, with one drop (0.05 ml) of 10% bergamot essential oil instilled into the aroma diffuser bottle using a Pasteur pipette. The diffuser was secured near the nasal area of the mask with a magnet, and participants were instructed to continuously sniff the aroma for one hour daily. Receives: Drug: Bergamot Essential Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring the relative concentration changes of oxyhemoglobin (HbO₂) and deoxyhemoglobin (deoxy-Hb) in cortical regions such as the frontal lobe, temporal lobe, and parietal lobe during near-infrared spectroscopy (NIRS) brain functional imaging.
Prior to the experiment, near-infrared brain functional imaging was conducted during resting and task states. Participants were provided with aromatherapy clips infused with either Mugwort volatile oil or Bergamot essential oil and instructed to smell the oils daily for one hour. After one month of this routine, follow-up near-infrared functional imaging was performed during resting and task conditions.
Measured: From enrollment to the completion of one month of treatment
Secondary outcomes (2)
Complete the questionnaire.
A baseline assessment was conducted using the Beck Depression Inventory prior to the commencement of the experiment, with a follow-up assessment performed one month later using the same standardised scale to evaluate changes in the severity of depression. The BDI-II scale ranges from 0 to 63 points, with diagnostic significance assigned to each score range as follows: 0-13 points: No depression or very mild depression 14-19 points: Mild depression 20-28 points: Moderate depression 29-63 points: Severe depression
Measured: From enrollment to the completion of one month of treatment
Complete the questionnaire.
A baseline assessment was conducted using the Hamilton Depression Scale prior to the commencement of the experiment, with a follow-up assessment performed one month later using the same standardised scale to evaluate changes in the severity of depression. The HAMD-24 scale ranges from 0 to 96 points, with diagnostic significance assigned to each score band as follows: 0-7 points: Normal; 8-20 points: Possible depression; 21-34 points: Confirmed depression; 35-96 points: Severe depression
Measured: From enrollment to the completion of one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind controlled trial was conducted with 60 eligible patients, evenly divided by gender into an experimental group and a control group, with 30 patients in each. The experimental group received inhalation therapy with CAVO, while the control group received inhalation of bergamot essential oil. Both groups inhaled one drop (0.05 ml per drop) of 10% concentration of either Artemisia capillaris volatile oil or bergamot essential oil via a dropper inserted into a perfume diffuser, which was secured near the nasal area of the mask with a magnet. Participants were instructed to continuously sniff for 1 hour daily. Blood pressure, heart rate, anxiety, depression, and sleep scale scores were measured before and after inhalation. Serum levels of cortisol, IL-1, IL-2, IL-6, and TNF-α were quantified to assess biochemical changes. Functional near-infrared spectroscopy (fNIRS) was used to measure the relative concentrations of oxyhemoglobin and deoxyhemoglobin in the cerebral
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongdong Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongdong Qin, Yunnan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384312
- Sponsor's protocol ID
- XS2022-015
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No consent for IPD sharing was obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Antidepressant Effects and Mechanism of Action of Cang-ai Volatile Oil Based on Near-Infrared Functional Brain Imaging and the NT-Trk Signalling Pathway
- ClinicalTrials.gov ID
- NCT07384312
- Acronym / sponsor ID
- XS2022-015
- Conditions
- Depression Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dongdong QinUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Feb 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.
This project plans to recruit 60 patients with depression, randomly assigning them to either the CAVO group or the bergamot essential oil group, with 30 participants in each. Quantitative measurement will be conducted using fNIRS technology to assess the impact of the intranasal CAVO pathway on brain functional connectivity during rest and brain activation during task performance. The antidepressant effects of CAVO will be evaluated using standardized depression scales, and target brain regions for CAVO's action will be identified through this process.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, double-blind controlled trial was conducted with 60 eligible patients, evenly divided by gender into an experimental group and a control group, with 30 patients in each. The experimental group received inhalation therapy with CAVO, while the control group received inhalation of bergamot essential oil. Both groups inhaled one drop (0.05 ml per drop) of 10% concentration of either Artemisia capillaris volatile oil or bergamot essential oil via a dropper inserted into a perfume diffuser, which was secured near the nasal area of the mask with a magnet. Participants were instructed to continuously sniff for 1 hour daily. Blood pressure, heart rate, anxiety, depression, and sleep scale scores were measured before and after inhalation. Serum levels of cortisol, IL-1, IL-2, IL-6, and TNF-α were quantified to assess biochemical changes. Functional near-infrared spectroscopy (fNIRS) was used to measure the relative concentrations of oxyhemoglobin and deoxyhemoglobin in the cerebral
| Arm | Type | Receives |
|---|---|---|
| CAVO group | Active comparator | Drug: Cang-ai Volatile OilThe experimental group received CAVO inhalation therapy, with 0.05 ml (1 drop) of 10% Artemisia absinthium volatile oil dripped into the aroma diffusion capsule using a Pasteur pipette. The capsule was secured near the participant's nose on the mask with a magnet, and they were instructed to continue inhaling continuously for 1 hour daily. |
| BEO Group | Active comparator | Drug: Bergamot Essential OilThe control group received BEO inhalation therapy, with one drop (0.05 ml) of 10% bergamot essential oil instilled into the aroma diffuser bottle using a Pasteur pipette. The diffuser was secured near the nasal area of the mask with a magnet, and participants were instructed to continuously sniff the aroma for one hour daily. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Meets the diagnostic criteria for depressive episodes as outlined in the fifth edition (revised) of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Meets the diagnostic criteria for depression syndrome as defined in Part 1: Diseases of the Terminology for Clinical Diagnosis and Treatment in Traditional Chinese Medicine, issued by the National Administration of Traditional Chinese Medicine in 2023.
- Scores on the 21-item Beck Depression Inventory (BDI) range from 10 to 15; scores on the 24-item Hamilton Depression Rating Scale (HAMD) range from 8 to 20.
- Has a normal olfactory function, no history of allergic or respiratory diseases, aged 18-26 years.
- At least one week prior to assessment, has not used antidepressants, other psychotropic medications, electroconvulsive therapy, or undergone transcranial magnetic stimulation or other physical therapies.
Key exclusion criteria (5 listed)
- Strict exclusion of individuals with a history of schizophrenia, alcohol dependence, or substance abuse.
- Presence of organic brain disease, endocrine disorders, or depression secondary to other mental illnesses.
- A score of ≥3 points on the suicidal item of the Hamilton Depression Rating Scale.
- Pregnant or lactating women, or those with a history of manic or hypomanic episodes.
- Family history of monomorphic or bipolar affective disorder.
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 |
|---|---|---|
| Cang-ai Volatile OilThe experimental group received CAVO inhalation therapy, during which one drop (0.05 ml) of 10% mugwort volatile oil was administered into the aromatherapy diffuser using a Pasteur pipette. The diffuser was secured near the participant's nose on the mask with a magnet, and subjects were instructed to continuously inhale for one hour each day. | Drug | CAVO group |
| Bergamot Essential OilThe control group received BEO inhalation therapy, during which one drop (0.05 mL per drop) of 10% mandarin essential oil was administered into the aroma diffuser using a Pasteur pipette. The diffuser was secured near the participant's nose with a magnet fixed to the mask. Participants were instructed to continue smelling the aroma for 1 hour daily. | Drug | BEO Group |
Primary outcome
Monitoring the relative concentration changes of oxyhemoglobin (HbO₂) and deoxyhemoglobin (deoxy-Hb) in cortical regions such as the frontal lobe, temporal lobe, and parietal lobe during near-infrared spectroscopy (NIRS) brain functional imaging.
Time frame: From enrollment to the completion of one month of treatment
Prior to the experiment, near-infrared brain functional imaging was conducted during resting and task states. Participants were provided with aromatherapy clips infused with either Mugwort volatile oil or Bergamot essential oil and instructed to smell the oils daily for one hour. After one month of this routine, follow-up near-infrared functional imaging was performed during resting and task conditions.
2 secondary outcomes
Complete the questionnaire.
Time frame: From enrollment to the completion of one month of treatment
Complete the questionnaire.
Time frame: From enrollment to the completion of one month of treatment
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 3 Feb 2026.
- Individual participant dataSharing planned: No. No consent for IPD sharing was obtained from participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cang-ai Volatile Oil and Bergamot Essential Oil in people with Depression Disorder, run by Dongdong Qin at 1 site in China.
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 8 inclusion and 5 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 3 Feb 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 China. 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?
Monitoring the relative concentration changes of oxyhemoglobin (HbO₂) and deoxyhemoglobin (deoxy-Hb) in cortical regions such as the frontal lobe, temporal lobe, and parietal lobe during near-infrared spectroscopy (NIRS) brain functional imaging. (time frame: From enrollment to the completion of one month of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.