Menu
Not yet recruiting NCT07690020

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

No phase Interventional Ischemic Stroke, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Getong Tongluo Capsule, Matched Starch Placebo Capsule, Standard Routine Therapy for Ischemic Stroke.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Acute. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Distribution of modified Rankin Scale (mRS) scores [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • Incidence of adverse events [Time frame: Through study completion, an average of 6 months]
Secondary outcome measures (8)
  • Athens Insomnia Scale (AIS) score [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • Activities of Daily Living (ADL) score [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • Hamilton Depression Rating Scale (HAMD) score [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • Hamilton Anxiety Rating Scale (HAMA) score [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • Montreal Cognitive Assessment (MoCA) score [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • MMSE score [Time frame: Baseline, 3-month follow-up and 6-month follow-up]
  • Incidence rate of drug-related adverse reactions [Time frame: Through study completion, an average of 6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Patients who received any preparations containing the same active ingredients as the study drug (e.g., Pueraria lobata) within 2 weeks prior to stroke onset.
  • Patients with a history of allergy to the study drug or preparations with identical active ingredients.
  • Patients who received antibiotics within 1 month before onset; those taking probiotics or prebiotics long-term; patients with a past or in-hospital confirmed gastrointestinal disease history.
  • Pregnant and lactating women.
  • Patients deemed unsuitable for participation in this trial at the investigator's discretion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07690020 · NFEC-2026-409

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗