Depression
Conditions
Interventions
Control group:Day 1: saffron brew (0.005 g)
Day 2 - day 8: fluoxetine (20 mg/day)+saffron brew (0.01 g/day)
Experimental group:Day 1: saffron brew (1.5 g)
Day 2 - day 8: fluoxetine (20 mg/day) + saffron brew (3 g/day)
Sponsors
Jiangsu Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the above Western diagnostic criteria for moderate-severe depression. (HAMD-24 score >=20 points; SDS score >=62 points). 2. 18 to 65 years of age, male or female, with a subjective desire to seek treatment and stick with the treatment. female patients should be treated at one week after the end of their menstrual period. 3. No other antidepressants were taken before this visit. 4. Willing to sign informed consent. 5. No major physical illness or serious chronic physical disease. 6. Meet the following requirements for sample collection of intestinal flora: (1) No antibiotics have been used in the recent 3 months, and no microecological preparations (such as intestinal probiotics, etc.) have been used in the recent 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. 7. Cooperating with the scale tests and sample collection.
Exclusion criteria
Exclusion criteria: 1. Patients with serious suicidal tendencies or self-injury behaviors. 2. Patients with non-depressive psychosis or bipolar disorder, schizophrenia, mental retardation and mental decline. 3. Patients with severe physical diseases (including but not limited to blood system, cardiovascular and cerebrovascular systems, digestive and respiratory systems, etc.). 4. Female patients in menstrual, pregnancy, lactation period. 5. With history of alcohol and drug abuse. 6. In the investigator's judgment, there are other factors that may cause the subject to be forced to terminate the study. 7. Allergic constitution, known to be allergic to fluoxetine or saffron or pharmaceutical excipients. 8. Patients who are participating in clinical trials of other drugs. 9. Those who refuse to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety observation;Outcome measure; | — |
Countries
China
Contacts
Public ContactWenzheng Ju
Jiangsu Province Hospital of Chinese Medicine
Outcome results
None listed