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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Cang-ai Volatile Oil (Drug)
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.
干预措施: Bergamot Essential Oil (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Complete the questionnaire.(From enrollment to the completion of one month of treatment)
研究者
Dongdong Qin
Researcher
Yunnan University of Chinese Medicine