Clinical Efficacy and Mechanism Research of Getong Tongluo Capsule in Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University

About this trial

The purpose of this single-center, randomized, double-blind, controlled trial is to clarify the clinical efficacy and safety of Getong Tongluo Capsule in patients with ischemic stroke. Combined with gut microbiome and metabolomics techniques, investigators will explore whether this medicine exerts neuroprotective effects via the gut-brain axis. Investigators will further verify its pharmacological mechanism through animal experiments to provide evidence for its clinical application.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent form

Aged between 18 and 80 years old

Conform to the diagnosis of acute ischemic stroke referring to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)

Hospital admission within 21 days after disease onset

Disqualifiers

Patients with mild or no neurological deficits on admission: those with a score of 0 on the Modified Rankin Scale (mRS) at admission (defined as completely asymptomatic).

Patients with severe baseline disability: those with a pre-stroke mRS score ≥ 3 (indicating moderate to severe disability requiring partial or full assistance with activities of daily living).

Patients with transient ischemic attack, concomitant cerebral hemorrhage or subarachnoid hemorrhage; those complicated with brain tumor, Alzheimer's disease, psychiatric disorders, or suspected pre-stroke cognitive dysfunction.

Patients complicated with severe cardiac diseases including valvular heart disease, infective endocarditis, myocardial infarction and heart failure; severe hepatic or renal insufficiency, respiratory failure, malignant tumors, or massive gastrointestinal hemorrhage.

Trial design

Treatments tested in this trial

  • Getong Tongluo Capsule
  • Matched Starch Placebo Capsule
  • Standard Routine Therapy for Ischemic Stroke

Treatment groups

216 Participants
are divided into 2 treatment groups

Locations

This trial has no locations