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

Phase 1
Not yet recruiting
Conditions
Post-ischemic Depression after Stroke
Registration Number
ITMCTR2000003713
Lead Sponsor
Shanghai Traditional Chinese Medicine Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
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

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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
TCM Syndrome Scale Score;Hamilton Depression Rating Scale;
Secondary Outcome Measures
NameTimeMethod
IHSS;Daily living ability scale score;
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