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Clinical Study on Xinyue Prescription Improving Cognitive Impairment of Senile Depression

Clinical Study on Xinyue Prescription Improving Cognitive Impairment of Senile Depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043474
Enrollment
Unknown
Registered
2021-02-19
Start date
2021-03-15
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Improving Cognitive Impairment of Senile Depression

Interventions

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. In line with the diagnostic criteria of depression and mild cognitive impairment in traditional Chinese medicine and western medicine, the score of Hamilton Depression Scale was 20-35, and the score of Montreal Cognitive Assessment Scale (Beijing version) was < 26. The TCM syndrome type was "Yin deficiency and liver depression, and no intercommunication between heart and kidney". 2. Male and female patients aged 60-85 years. 3. Patients first depressive episode after age 60. 4. Primary school education or above. 5. Signed Informed Consent. 6. Good compliance.

Exclusion criteria

Exclusion criteria: 1. Organic or drug caused by secondary depression disorder. 2. Depressive disorder secondary to schizophrenia and other psychiatric disorders. 3. Severe affective disorder, depressive episode of bipolar disorder, reactive depressive disorder and other disease states of depressive syndrome. 4. Patients who have taken sedative sleeping pills, other drugs that have effects on cognitive function or antidepressants within the last 2 weeks. 5. Dependence or abuse of alcohol or other substances. 6. Suicide score > 2 on HAMD scale. 7. Complicated with severe liver and kidney dysfunction, other serious primary diseases that affect life span, tumors, organic brain diseases, visual and hearing impairment, etc. 8. Previous dementia patients. 9. Cannot cooperate to complete the test. 10. Have a history of severe drug allergy.

Design outcomes

Primary

MeasureTime frame
HAMD depression scale score;MoCA scale score;

Secondary

MeasureTime frame
TCM syndrome scores;BDNF, IL-1ß, IL-6 and TNF-a;

Countries

China

Contacts

Public ContactGuo Ming-Dong

Xiyuan Hospital, China Academy of Chinese Medical Sciences

drgmd@163.com+86 13522593516

Outcome results

None listed

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