Teenagers' depression disorders
Conditions
Interventions
Experimental group:Shugan Granules + "Sound AI Emotional Assistant" Shugan Granules, Oral, 1 at a time Bag, 2 times a day, warm boiled water
Control group:Shugan Granule Simulator + "Sound AI Emotional Assistant" Shugan Granule Simulator, oral, 1 bag at a time, 2 times a day, washed with warm water
Sponsors
Oriental Hospital of Beijing University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have clinically confirmed depressive disorder and have not used Western medicine for antidepressive disorder; 2. Meet the syndrome differentiation standards for liver qi stagnation in traditional Chinese medicine; 3. The severity is mild or moderate the total score of HAMD-17 is >7 points =24 points and item 3 (suicide) =2 points; 4. 12 years old=age <18 years old; 5. Subjects and her/his guardians understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Hamilton Anxiety Scale (HAMA) Total Score =29 points; 2. Schizophrenia and other primary psychotic disorders, bipolar disorders, sperm Depressive disorders, organic mental disorders, compulsive and related disorders caused by divine active substances Depression disorders caused by related disorders such as disorders, trauma and stress, and neurodevelopmental disorders hinder; 3. Depressive disorders secondary to other physical diseases, such as bronchial asthma, diabetes disease, hyperthyroidism or hypothyroidism, irritable bowel syndrome, etc.; 4. Patients with co-affected attention deficits and hyperactivity disorder; 5. Combined with serious primary diseases such as heart, brain, liver, kidney, hematopoiesis, urogenital and other systems Patients with disease; 6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST)>On normal value Limit 2 times, blood creatinine (Scr)> upper limit of normal value; 7. Those who are allergic to any ingredient of the drug used in the test; 8. Patients who participated in or are participating in other clinical trials within 1 month before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with hamd17 score drop rate > 50% in the treatment of week 8.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of TCM syndrome during treatment;Treatment of the variation values of miR-132, miR-124, IL-6, COR, hs-CRP, SOD, ATP during week 8;Change of HAMA score during treatment;Changes in sleep-related score of HAMD-17 during treatment;Change of HAMD-17 score during treatment;Score change value of Parental Correctional Behavior Questionnaire (APQ-9) during treatment; | — |
Countries
CHINA
Contacts
Public ContactGuo Rongjuan
Oriental Hospital of Beijing University of Traditional Chinese Medicine
Outcome results
None listed