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Clinical efficacy and effect mechanism of Morinda officinalis oligosaccharide capsules in the treatment of vascular depression based on the brain-gut axis

Clinical efficacy and effect mechanism of Morinda officinalis oligosaccharide capsules in the treatment of vascular depression based on the brain-gut axis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049044
Enrollment
Unknown
Registered
2021-07-20
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Vascular depression

Interventions

Morinda officinalis oligose capsule group:Morinda officinalis oligose capsule
Placebo group:Placebo

Sponsors

Beijing University of Chinese Medicine Dongfang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for vascular depression; 2. Meet the diagnostic criteria of TCM syndrome of kidney deficiency and liver stagnation; 3. Age >= 60 years old; 4. 7 points<=HAMD (17 items)<=24 points; 5. No antidepressant-related western medicine treatment in the past 2 weeks; 6. Voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Brain MRI shows that the axial extent of cerebral infarction is more than 20mm; 2. Patients with severe neurological deficits such as hemiplegia, aphasia, and agnosia and dementia (MMSE score: illiteracy <=17 points, primary school education level <=20 points, secondary school education level <=24, etc.); 3. Patients with bipolar disorder, schizophrenia, refractory depression or suicidal tendencies; 4. Found patients with serious organic diseases such as heart, liver and kidney; 5. The head and neck arteries have been treated with endarterectomy or stenting; 6. Suffering from cerebral vasculitis, intracranial aneurysm, encephalitis, meningitis, intracranial vascular malformation, brain tumor, etc.; 7. Patients with epilepsy, poisoning, drug abuse, innate immune diseases, and genetic diseases; 8. Have a history of allergies to multiple drugs.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale 17;

Secondary

MeasureTime frame
Montreal Cognitive Assessment;Hamilton Anxiety Scale;Athens Insomnia Scale;TCM syndrome scores;Fazekas scale;Activity of Daily Living score;

Countries

China

Contacts

Public ContactGuo Rongjuan

Beijing University of Chinese Medicine Dongfang Hospital

dfguorongjuan@163.com+86 18611377633

Outcome results

None listed

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