Clinical Study of Cang Ai Volatile Oil (CAVO) on Mild to Moderate Depression in Children and Adolescents
Depression
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Children, Adolescents, Aromatic Chinese Medicine
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Sites / Locations
- Yunnan Provincial Hospital of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Sham Comparator
Test group
Positive drug group
Blank control group
CAVO aromatherapy patch at 3% concentration (continue sniffing for 15 minutes )and Fluoxetine Hydrochloride mimetic (20mg/tablet,once a day,10mg each time)
CAVO aromatherapy patch at 0.1% concentration(continue sniffing for 15 minutes ) and Fluoxetine hydrochloride tablet (20mg/tablet,once a day,10mg each time)
Concentration 0.1% CAVO aromatherapy patch(continue sniffing for 15 minutes)and fluoxetine hydrochloride mimetic(20mg/tablet,once a day,10mg each time)