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A Randomized Controlled Clinical Study of Nerve Fuyuan Decoction in the Treatment of Post-Ischemic Depression After Stroke

A Randomized Controlled Clinical Study of Nerve Fuyuan Decoction in the Treatment of Post-Ischemic Depression After Stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036944
Enrollment
Unknown
Registered
2020-08-25
Start date
2021-04-01
Completion date
Unknown
Last updated
2020-09-28

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

Conditions

Post-ischemic Depression after Stroke

Interventions

Sponsors

Shanghai Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of ischemic stroke confirmed by CT or MRI; 2. The diagnosis meets the above-mentioned diagnostic criteria for cerebral infarction and depression, and the two are related. Depression occurs within 1 year after stroke; 3. Age >= 50 years old and <= 80 years old; 4. The TCM syndrome is the syndrome of phlegm and blood stasis obstructing collaterals; 5. 7 points < HAMD <= 24 points; 6. Be able to read and understand the contents of various scales used in the survey proficiently, and have no obvious obstacles to expression and communication; 7. Before treatment, liver and kidney functions were normal, vital signs were stable, consciousness was clear, and there was no previous mental illness; 8. Voluntarily accept the observation of this clinical trial, have good compliance, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Stroke caused by tumor and blood disease; 2. Patients with severe heart, liver, spleen, lung, kidney, hematopoietic system, bone and joint diseases, severe infections; 3. Those with unstable vital signs or with severe heart, liver, and kidney system diseases; those with severe hypertension (blood pressure> 180/120mmHg), and those who are not satisfied with the control; 4. Patients with limb dysfunction, severe aphasia, agnosia, and unable to communicate due to a history of severe stroke; 5. Past history of psychosis, depression and family history of psychosis; 6. People with allergies and allergies to known ingredients of the test drug and the control drug. 7. Participate in other clinical trials within the past 3 months; 8. Women during pregnancy and lactation; 9. Persons with a history of drug abuse or alcohol abuse; combined use of western antidepressant drugs.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale;TCM Syndrome Scale Score;

Secondary

MeasureTime frame
Daily living ability scale score;NIHSS;

Countries

China

Contacts

Public ContactCai Li

Shanghai Traditional Chinese Medicine Hospital

cailys@163.com+86 18116013387

Outcome results

None listed

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