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

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 Overview

• Status: Completed
• Conditions: Depression Disorder
• Intervention / Treatment: Drug: Cang-ai Volatile Oil; Drug: Bergamot Essential Oil

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650500
      • Yunnan University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion：

1. 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).
2. 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.
3. 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.
4. Has a normal olfactory function, no history of allergic or respiratory diseases, aged 18-26 years.
5. 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.
6. Exhibits depressive symptoms persisting for more than two weeks.
7. Right-handed.
8. Approved by the hospital ethics committee; all participants volunteer and have provided written informed consent.

Exclusion ：

1. Strict exclusion of individuals with a history of schizophrenia, alcohol dependence, or substance abuse.
2. Presence of organic brain disease, endocrine disorders, or depression secondary to other mental illnesses.
3. A score of ≥3 points on the suicidal item of the Hamilton Depression Rating Scale.
4. Pregnant or lactating women, or those with a history of manic or hypomanic episodes.
5. Family history of monomorphic or bipolar affective disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CAVO group; 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.	Drug: Cang-ai Volatile Oil; 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.
Active Comparator: BEO Group; 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.	Drug: Bergamot Essential Oil; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Dongdong Qin

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: XS2022-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No consent for IPD sharing was obtained from participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No