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NOT YET RECRUITING
NCT07690020
NA

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

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-08-01

Completion Date

2030-01-31

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

Getong Tongluo Capsule

Oral proprietary Chinese medicine for convalescent ischemic stroke. Subjects take 2 capsules (0.25 g each), twice daily, on top of guideline-standardized antiplatelet, lipid-lowering, antihypertensive and hypoglycemic routine stroke treatment. Treatment period ranges from 14±7 days to 6 months after stroke onset.

OTHER

Matched Starch Placebo Capsule

Starch-filled blank capsules identical to Getong Tongluo Capsule in appearance, size and taste. Subjects take 2 capsules (0.25 g each), twice daily together with standardized basic stroke therapy, for 14±7 days to 6 months post stroke.

DRUG

Standard Routine Therapy for Ischemic Stroke

Individualized guideline-directed basic stroke care including antiplatelet, lipid-regulating, blood pressure and glucose lowering medications, provided to all participants in both treatment and placebo arms throughout the study.