depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the Western medical diagnostic criteria for depression; (2) Meet the Chinese medicine diagnostic criteria for heart-kidney disorders; (3) Those aged between 18 and 65 years old; (4) Scores =5 and <15 on the PHQ-9 Depression Screening Scale and =9 on the GAD-7 Anxiety Disorder Screening Scale; (5) Hamilton Depression Scale (HAMD) 24-item score =20 and <35; (6) Hamilton Anxiety Scale (HAMA) with a total score of =21 with a score of =2 for depressive state of mind (item 6) and <3 for anxious state of mind (item 1); (7) Depression self-assessment scale (SDS) standard score =50 and <70; (8) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Depressive episodes secondary to other psychiatric or somatic disorders and those with severe psychotic symptoms e.g. bipolar disorder refractory depression; (2) Significant anxiety (HAMA total score > 21); (3) Persons with allergies or previous allergies to study medications; (4) Those with suicidal tendencies; (5) Intracranial cerebrovascular disease neurodegenerative diseases intracranial tumours and systemic disorders such as hypertension and diabetes mellitus that lead to abnormal vascular distribution or blood flow in the brain; (6) Combined serious diseases of other systems as well as serious cardiac hepatic and renal insufficiency; (7) Patients with glaucoma and epilepsy; (8) Those taking antibiotics probiotics and other intestinal microecological agents at the same time; (9) Those who have had significant diarrhoea or constipation in the last two weeks or those who have undergone gastroenteroscopy; (10) Those who are pregnant or breastfeeding or intending to become pregnant and those who have a positive urine pregnancy test in women of childbearing age; (11) Patients who have been or will be enrolled in another observational drug study within 30 days; (12) Other conditions that in the opinion of the investigator exist that make participation in the trial unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chinese Medicine Certificate Evaluation Scale;Hamilton Depression Scale;Depression Self-Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic information; | — |
Countries
China
Contacts
Tianjin University of traditional Chinese medicine