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Study of efficacy and safety of Jiaotai pill in the treatment of depression

Study of brain mechanism of Jiaotai pill treating on depression by functional magnetic resonance imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17010748
Enrollment
Unknown
Registered
2017-02-28
Start date
2017-03-21
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

experimental group:Jiaotai pill + fluoxetine hydrochloride
control group: fluoxetine hydrochloride

Sponsors

Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Conform to depression diagnostic criteria of "American psychiatric diagnosis standard" Fourth Edition (DSM-IV); Accord with the diagnostic criteria of TCM syndrome of depression in disharmony of heart and kidney; HAMD 24 items score of more than 20 points and less than 35 points; Aged 18-65 years; The total score of HAMA less than 21 points, depressed mood (item 6) score more than 2 points, anxious mood (item 1) score less than 3 points; Not taking antidepressants or taking medicine but has stopped for two weeks; Sign the informed consent.

Exclusion criteria

Exclusion criteria: Secondary to other mental illnesses or physical illness and depression with severe psychotic symptoms; Severe anxiety (HAMA total score more than 21 points); Allergic constitution or previous research on drug allergy; Suicidal person; Bipolar disorder, refractory depression (application of two or more different chemical structure of antidepressants, the full amount, full course of treatment is invalid or ineffective); Intracranial cerebrovascular disease, neurodegenerative diseases, intracranial tumor, and high blood pressure, diabetes and so on of leading to brain vascular distribution or abnormal blood flow of systemic disorders; with serious diseases of other systems, and severe heart, liver and renal insufficiency; Glaucoma and epilepsy; Pregnancy or lactation or quasi pregnancy; Urine pregnancy test positive for women of childbearing age; MR inspection contraindications or cannot cooperate complete MR scan or can not adapt to the environment and noise of MRI scan; Already or will take part in other drugs observational study of patients within 30 days; Poor compliance is expected, unable to interview regularly; Researchers believe there are other conditions not suitable for the trial.

Design outcomes

Primary

MeasureTime frame
HAMD;TCM syndrome score;WCST;urine metabolism;blood metabolism;functional magnetic resonance imaging;NE;DA;5-HT;

Countries

China

Contacts

Public ContactZhihuan Zhou

Tianjin University of Traditional Chinese Medicine

kfzzh@126.com+86 022-59596119

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026