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NCT Number: NCT07690020

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

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.

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Key information

Conditions

Ischemic Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Getong Tongluo Capsule

Drug

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.

Matched Starch Placebo Capsule

Other

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.

Standard Routine Therapy for Ischemic Stroke

Drug

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 outcomes

  1. Distribution of modified Rankin Scale (mRS) scores

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    Scores range from 0 (no symptoms) to 6 (death); higher scores indicate poorer functional recovery

  2. Incidence of adverse events

    Time frame: Through study completion, an average of 6 months

Secondary outcomes

  1. Athens Insomnia Scale (AIS) score

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    Total score ranges from 0 to 24; higher scores indicate more severe insomnia (worse sleep condition)

  2. Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    The scale evaluates six TCM syndrome elements (endogenous wind, internal fire, blood stasis, phlegm-dampness, qi deficiency, yin deficiency) with weighted symptom scores for each element. Higher subscores for each syndrome element represent more severe relevant syndrome manifestations.

  3. Activities of Daily Living (ADL) score

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    Total score ranges from 0 to 100; higher scores indicate superior independent daily function

  4. Hamilton Depression Rating Scale (HAMD) score

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    Total score ranges from 0 to 52; higher scores indicate more severe depressive symptoms

  5. Hamilton Anxiety Rating Scale (HAMA) score

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    Total score ranges from 0 to 56; higher scores indicate more severe anxiety symptoms

  6. Montreal Cognitive Assessment (MoCA) score

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    Total score ranges from 0 to 30; higher scores indicate better cognitive function.

  7. MMSE score

    Time frame: Baseline, 3-month follow-up and 6-month follow-up

    Total score ranges from 0 to 30; higher scores indicate better cognitive performance

  8. Incidence rate of drug-related adverse reactions

    Time frame: Through study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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