Skip to main content
OpenTrials
Completed

NCT Number: NCT07384312

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Disorder

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunnan University of Chinese Medicine

Kunming, Yunnan, 650500, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion：

  • 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.

Exclusion ：

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complete the questionnaire.

    Time frame: From enrollment to the completion of one month of treatment

    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

  2. Complete the questionnaire.

    Time frame: From enrollment to the completion of one month of treatment

    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

Sponsors and collaborators

Lead sponsor

Dongdong Qin

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.