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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke, Acute
• Intervention / Treatment: Drug: Getong Tongluo Capsule; Drug: Standard Routine Therapy for Ischemic Stroke; Other: Matched Starch Placebo Capsule

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form
2. Aged between 18 and 80 years old
3. Conform to the diagnosis of acute ischemic stroke referring to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)
4. Hospital admission within 21 days after disease onset

Exclusion Criteria:

1. 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).
2. 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).
3. 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.
4. 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.
5. 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.
6. Patients with a history of allergy to the study drug or preparations with identical active ingredients.
7. 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.
8. Pregnant and lactating women.
9. Patients deemed unsuitable for participation in this trial at the investigator's discretion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	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.; 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.
Placebo Comparator: Placebo group	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of modified Rankin Scale (mRS) scores	Scores range from 0 (no symptoms) to 6 (death); higher scores indicate poorer functional recovery	Baseline, 3-month follow-up and 6-month follow-up
Incidence of adverse events		Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Athens Insomnia Scale (AIS) score	Total score ranges from 0 to 24; higher scores indicate more severe insomnia (worse sleep condition)	Baseline, 3-month follow-up and 6-month follow-up
Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement	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.	Baseline, 3-month follow-up and 6-month follow-up
Activities of Daily Living (ADL) score	Total score ranges from 0 to 100; higher scores indicate superior independent daily function	Baseline, 3-month follow-up and 6-month follow-up
Hamilton Depression Rating Scale (HAMD) score	Total score ranges from 0 to 52; higher scores indicate more severe depressive symptoms	Baseline, 3-month follow-up and 6-month follow-up
Hamilton Anxiety Rating Scale (HAMA) score	Total score ranges from 0 to 56; higher scores indicate more severe anxiety symptoms	Baseline, 3-month follow-up and 6-month follow-up
Montreal Cognitive Assessment (MoCA) score	Total score ranges from 0 to 30; higher scores indicate better cognitive function.	Baseline, 3-month follow-up and 6-month follow-up
MMSE score	Total score ranges from 0 to 30; higher scores indicate better cognitive performance	Baseline, 3-month follow-up and 6-month follow-up
Incidence rate of drug-related adverse reactions		Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Acute Ischemic Stroke; Post-acute Ischemic Stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NFEC-2026-409

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No