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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cang-ai Volatile Oil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the completion of one month of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion：
Exclusion ：
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunnan University of Chinese Medicine | Kunming | Yunnan | 650500 | China |
No consent for IPD sharing was obtained from participants.
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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
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| Bergamot Essential Oil | Drug | 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. |
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| 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 | From enrollment to the completion of one month of treatment |