Clinical Study of Cang Ai Volatile Oil (CAVO) on Mild to Moderate Depression in Children and Adolescents
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Serum glutamate, gamma-aminobutyric acid, 5-hydroxytryptamine levels.
研究概览
简要总结
A randomized controlled trial was conducted to observe the improvement of mild to moderate depressive symptoms in children and adolescents with the aromatic herbal compound Cang Ai Volatile Oil (CAVO) and to evaluate the effectiveness and safety of the clinical application of CAVO.
详细描述
The trial was divided into: screening period, pre-treatment period, treatment period (first session, second session) and follow-up period.
(1) Screening period (14 days before intervention to 2 days before intervention): 108 patients with mild to moderate adolescent depression, regardless of gender, are to be enrolled. Patients will sign an informed consent form and will complete the screening period from the 14th pre-intervention day to the 2nd pre-intervention day.
(2) Pre-treatment (1 day prior to intervention): Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will obtain a randomisation number 1 day prior to dosing and will be randomised in a 1:1:1 ratio to either the trial group (Group A), positive drug group (Group B) or blank control group (Group C). Subjects undergo an alcohol breath test and urine drug screen on an empty stomach at the test site to determine if they meet the entry criteria. Blood tests will be taken on an empty stomach on the day of the trial for testing, followed by food and 30 minutes later, blood pressure and EEG measurements will be taken and a depression scale will be completed after completion of NIR brain function measurements.
(3) Treatment period (first course: weeks 1 to 4, second course: weeks 5 to 8).
- Test group: Each subject was given a sufficient amount of CAVO aromatherapy patch + fluoxetine hydrochloride mimetic at a concentration of 3%. The subject was instructed to fix the aromatherapy patch on the near-nasal part of the mouthpiece daily and complete two sniffing inhalations at fixed times (07:45-08:00 and 19:45-20:00) daily during the course of the treatment period, each time for 15 minutes, and to take 1 tablet of fluoxetine mimetic orally once a day. times.
- Positive drug group: Each subject was given a sufficient amount of CAVO aromatherapy patch + fluoxetine hydrochloride tablet (20mg/tablet) at a concentration of 0.1%, and was instructed to take fluoxetine hydrochloride tablet (20mg/tablet) orally (10mg/dose, once a day). The aromatherapy patch was applied to the nasal area of the mask once a day.
- Blank control group: Subjects were given a sufficient amount of CAVO aromatherapy patch + fluoxetine hydrochloride mimetic (20mg/tablet) at a concentration of 0.1% and were instructed to fix the aromatherapy patch on the near nasal area of the mouthpiece twice a day during the treatment period at fixed times (07:45-08:00 and 19:45-20:00) and to take 1 tablet of fluoxetine mimetic by mouth for 15 minutes each time. tablet of fluoxetine mimetic (20mg/tablet), 10mg/dose, once a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and International Classification of Diseases (ICD) 10th Revision diagnostic criteria for mild to moderate depressive episodes, either first or recurrent, and not accompanied by psychotic symptoms.
- •Meeting the diagnostic criteria for depression in Chinese medicine.
- •10 to 18 years of age (including borderline values), either sex.
- •Depression scale: BDI-2, HAMD depression scale score of mild to moderate
- •Healthy sense of smell, no allergic diseases or respiratory diseases.
- •Have not used antidepressants and other psychiatric drugs or physiotherapy such as electroconvulsive or transcranial magnetic stimulation for at least 1 week prior to the examination.
- •Depressive episodes lasting 2 weeks or more.
- •All subjects have volunteered to participate and signed an informed consent form, as approved by the hospital's ethics committee.
排除标准
- •A history of alcohol and drug dependence is strictly excluded.
- •Current or prior diagnosis of a major psychiatric disorder other than depression consistent with DSM-5, such as bipolar disorder, neurodevelopmental disorder, neurocognitive disorder, schizophrenia, psychotic disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, antisocial personality disorder, etc.
- •Depression with a history of organic brain disease and endocrine disorders or secondary to other psychiatric disorders.
- •Persons at high risk of suicide: e.g., suicide attempts, recent suicide attempts, and those without family supervision
- •Those with a history of manic or hypomanic episodes.
- •Regularly taking antidepressants within 2 weeks prior to screening and not having discontinued psychotropic medication for 7 half-lives (at least 2 weeks for monoamine oxidase inhibitors and at least 1 month for fluoxetine) prior to randomisation to the group.
- •Patients who have received physical therapy such as MECT, TMS, Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), and other treatments such as light therapy, music therapy, exercise therapy, and acupuncture in the 3 months prior to screening.
- •Patients with severe or unstable cardiovascular, respiratory, hepatic, renal, endocrine, haematological or other systemic disease which, in the opinion of the investigator, makes them unsuitable for enrollment in this study.
- •Persons with known hypersensitivity to the test drug, or who are allergic.
- •Those who have used the clinical trial drug within 3 months prior to the first dose, or those who plan to participate in other clinical trials during this study (ask, enquire).
研究组 & 干预措施
Test group
CAVO aromatherapy patch at 3% concentration （continue sniffing for 15 minutes ）and Fluoxetine Hydrochloride mimetic （20mg/tablet，once a day，10mg each time）
干预措施: CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic (Drug)
Positive drug group
CAVO aromatherapy patch at 0.1% concentration（continue sniffing for 15 minutes ） and Fluoxetine hydrochloride tablet （20mg/tablet，once a day，10mg each time)
干预措施: Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration (Drug)
Blank control group
Concentration 0.1% CAVO aromatherapy patch（continue sniffing for 15 minutes）and fluoxetine hydrochloride mimetic（20mg/tablet，once a day，10mg each time）
干预措施: Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration (Drug)
结局指标
主要结局
Serum glutamate, gamma-aminobutyric acid, 5-hydroxytryptamine levels.
时间窗: 3 months
Serum glutamate in μmol/L, Gamma-aminobutyric acid in μmol/L, 5-hydroxytryptamine in μmol/L
The score of Hamilton Depression Scale(HAMD),Children's Depression Inventory(CDI).
时间窗: 3 months
The score of Hamilton Depression Scale(HAMD)\>20，Total score 80 points，a total score of more than 35 on 24 items is considered severe depression, more than 20, possibly mild or moderate depression, and if less than 8, the patient has no depressive symptoms. The score of Children's Depression Inventory(CDI)\>19，A scale of 0, 1 and 2 was used, indicating "occasionally", "often" and "always" respectively, indicating the frequency of symptoms, with a total score of 54. According to the original scale norm, 19 is the cut-off score for determining depressive symptoms, the higher the score the more severe the depression.
Serum pro-inflammatory cytokine assays, anti-inflammatory cytokines.
时间窗: 3 months
Serum pro-inflammatory cytokine assays include Tumour necrosis factor-alpha in pg/mg; Interleukin-1β in pg/mg; Interleukin-6 in pg/mg; Interferon gamma in pg/mg; Anti-inflammatory cytokines include Transforming growth factor-β in pg/mg; Interleukin-10 in pg/mg; Interleukin-4 in pg/mg; Interleukin-8 in pg/mg
HPA axis function test
时间窗: 3 months
Adrenocorticotropin-releasing hormone in μIU/ml； Pro-adrenocorticotropic hormone in μ IU/ml； Cortisol in μIU/ml
次要结局
- Safety indicators Safety indicators(3 months)
- Physical examination indicators（Liver function and kidney function）(3 months)
研究者
Chen Qian
Yunnan University of Chinese Medicine
Yunnan University of Chinese Medicine