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Study on the Therapeutic Effect and Mechanism of Bushen Yisui Capsules Against Multiple Sclerosis with Depression Based on Multi-modality Analysis

Phase 1
Recruiting
Conditions
multiple sclerosis
Registration Number
ITMCTR2000003158
Lead Sponsor
Beijing Tiantan Hospital, Capital Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Meets the 2010 McDonald MS diagnostic criteria;
2. Meet the International Standard for Classification and Diagnosis of Diseases (ICD-10 diagnostic criteria for mild and moderate depression (F32) depression, first diagnosis, first treatment;
3. HAMD-24 item scale score >= 20 points and < 35 points;
4. Age over 18 years and under 65 years;
5. MRI demyelination site in the skull;
6. Subjects volunteered and signed informed consent.

Exclusion Criteria

1. Other treatments were performed before the start of this study;
2. Patients with acute MS who have a cortical state or coma;
3. Suffering from severe heart, liver and kidney dysfunction and other diseases that affect the stability of vital signs;
4. Patients during pregnancy or lactation;
5. People who have a significant tendency to commit suicide;
6. Serious adverse reactions in nuclear magnetic (MRS, DTI) scans that make the examination impossible;
7. In any other situation that the researcher considers unsuitable to participate in this trial, such as failure to cooperate with nuclear magnetic scanning as required by the research;
8. Patients with MS who have entered a relapse period during follow-up.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fractional Anisotropy, FA;HAMD-24;The Kurtzke Expanded Disability Status Scale (EDSS);IL-2;5-HT;IL-13;QIDS;TNF-a;IL-12;IL-6;IL-1ß;Apparent Diffusion Coefficient, ADC;IL-4;AIDS;
Secondary Outcome Measures
NameTimeMethod
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