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

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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220419008
Enrollment
71
Registered
2022-04-19
Start date
2022-04-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Stroke is a common clinical acute cerebrovascular disease. Patients may have dysfunction of consciousness,movement,sensation or speech. It is characterized by rapid onset, rapid disease progression, poor prognosis and high disability and mortality rates, which seriously affect the quality of life of patients and impose a huge burden on their families and society. Minocycline has certain advantages in the long-term efficacy of neurological recovery in acute stroke patients, but there is a lack of

Interventions

This study will screen patients who meet the criteria for this study by recruiting at the hospital.A randomized, double-blind, placebo-controlled study will be conducted, in which the treatment group:
the control group: placebo is orally administered at 200 mg/d for 2 weeks, and the placebo is treated in accordance with the original drug in appearance, odor and taste for 2 weeks.Patients in both gr
atorvastatin calcium tablets 20 mg/d for lipid regulation. Avoid smoking, alcohol and irritating food during medication, pay attention to resting, monitors liver and kidney function and adverse reacti
s condition. If necessary, the attending physician can appropriately adjust the protocol according to the patient&#039
s condition. All intervention methods will be recorded in detail and used for the final result analysis. During the trial, the investigators and subjects do not know their groups, the efficacy evaluat
Experimental Other
minocycline

Sponsors

Min Zhao
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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: 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

Design outcomes

Primary

MeasureTime frame
Neurological function will be assessed by NIHSS 14 days NIHSS stroke scale includes 11 items such as consciousness, gaze, visual field, and movement,

Secondary

MeasureTime frame
Activities of daily living will be assessed by BI 14 days The Barthel index score ranged from 0 to 100

Countries

China

Contacts

Public ContactChunyan Zhang

Linfen People Hospital

biashfad@126.com18822557849

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026