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ong-term efficacy and adverse events of minocycline on neurological recovery in patients with acute stroke: A randomized, double-blind, placebo-controlled trial protocol

Phase 1
Registration Number
TCTR20220419008
Lead Sponsor
Min Zhao
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
71
Inclusion Criteria

1.Patients diagnosed with acute stroke . 2.Over 18 years of age.3.Patients with stable vital signs.4.Voluntarily participate in this study and sign the informed consent.5.Have certain expression, understanding and communication ability.6.Complete clinical data.

Exclusion Criteria

Exclusion criteria (Criteria used to identify patients unable to participate in the trial): 1.Patients with malignant tumor, immune or hematopoietic system diseases.2.Patients with other infectious diseases.3.Patients with severe kidney, liver and heart disease.4.Patients with severe mental illness or disturbance of consciousness.5.Patients who cannot understand the study protocol or participants after explanation.
Exclusion criteria (Criteria for judging that patients who have participated in the trial cannot continue to participate in the trial): 1.Serious adverse events occur that are not suitable for the next step of the trial.2.Poor compliance, affecting the efficacy judgment.3.Disease progression during treatment, need to change the treatment regimen.4.For any reason, the subject asked to withdraw from the trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
eurological function will be assessed by NIHSS 14 days NIHSS stroke scale includes 11 items such as consciousness, gaze, visual field, and movement,
Secondary Outcome Measures
NameTimeMethod
Activities of daily living will be assessed by BI 14 days The Barthel index score ranged from 0 to 100
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