major depressive disorder
Conditions
Interventions
Liver qi stagnation type group:Patients with liver-qi stagnation type depression were treated with Chaihu Shugan powder
Heart kidney not cross type group:Patients with heart-kidney disjunction type depression were treated with Jiaotai pills and granules
Healthy control group:None
Sponsors
Jiangsu Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Treatment group: (1) Mild to moderate patients who meet the Western diagnostic criteria for depression. (7-24 on HAMD-17; SDS score 53-72 points), and those who met the criteria for TCM syndrome differentiation of mild and moderate (severity score 4-9 points). (2) Aged between 14 and 65 years, no gender limit, subjective desire to seek treatment, cooperate with treatment and willing to adhere to traditional Chinese medicine treatment. (3) The duration of the visit was within 3-6 months, and no other western antidepressant drugs were taken; Or, although they had taken Western antidepressants, they had stopped taking them for more than a week at the time of enrollment. (4) The process of obtaining informed consent conforms to the provisions of GCP. Patients under 18 years old need to obtain informed consent from themselves and their guardians at the same time. (5) Prior good health with no major physical illness and/or serious poorly controlled chronic physical disease. (6) Able to consistently cooperate with the completion of two test scale tests and the collection of hematuria stool specimens. (7) Meet the following dietary and medication requirements for fecal sample collection of intestinal flora: 1) No antibiotics have been used in the past 3 months, and no microecological preparations (such as intestinal probiotics, etc.) have been used in the past 1 month; 2) No patients with primary or secondary infectious diseases (such as cholecystitis, pneumonia, etc.) in the past month; 3) No family history of inflammatory bowel disease or inflammatory bowel disease; 4) Patients with no history of abdominal surgery. 2. Control group: (1) Healthy volunteers undergoing physical examination in our hospital. (2) Aged between 14 and 65 years, no gender limit. (3) Physical examination, white blood cell count, ALT, AST, BUN, Cr, electrocardiogram and chest X-ray were all in the normal range. (4) Informed consent, voluntary subjects, the process of obtaining informed consent should conform to ethical principles. (5) Meet the following dietary and medication requirements for fecal sample collection of intestinal flora: 1) No antibiotics have been used in the past 3 months, and no microecological preparations (such as intestinal probiotics, etc.) have been used in the past 1 month; 2) No patients with primary or secondary infectious diseases (such as cholecystitis, pneumonia, etc.) in the past month; 3) No family history of inflammatory bowel disease or inflammatory bowel disease; 4) Patients with no history of abdominal surgery.
Exclusion criteria
Exclusion criteria: 1. Treatment group: (1) Patients with unstable vital signs or complicated with severe diseases of liver and kidney system; (2) Severe aphasia, loss of recognition and inability to communicate; (3) Severe depression or mild to moderate depression with serious suicidal tendencies; (4) Patients with non-depressive psychosis or bipolar disorder diagnosed by western medicine; Patients with schizophrenia, mental retardation and mental decline; (5) Those who refuse to sign written agreements and undertake corresponding obligations. 2. Control group: (1) Pregnant and lactating patients; (2) Serious primary diseases of heart, liver, lung, kidney and hematopoietic system; (3) Unable to give full informed consent due to intellectual or behavioral disabilities; (4) Suspected or confirmed history of alcohol and drug abuse; (5) Family history of inflammatory bowel disease; (6) Patients with legal disabilities (blind, deaf, dumb, mentally handicapped, mentally handicapped, physically handicapped).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intestinal flora;endogenous substance; | — |
Secondary
| Measure | Time frame |
|---|---|
| self-rating depression scale;Hamilton's depression scale;self-rating anxiety scale;Hamilton anxiety scale;Pittsburgh sleep scale; | — |
Countries
China
Contacts
Public ContactWang Xiaoyong
Jiangsu Provincial Hospital of Chinese Medicine
Outcome results
None listed