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

NCT07690020 | Not Yet Recruiting

• 1 other identifier: NFEC-2026-409
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemic Stroke, Acute

Keywords

Post-acute Ischemic Stroke; Ischemic Stroke; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Athens Insomnia Scale (AIS) score

  Baseline, 3-month follow-up and 6-month follow-up

• Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement

  Baseline, 3-month follow-up and 6-month follow-up

• Activities of Daily Living (ADL) score

  Baseline, 3-month follow-up and 6-month follow-up

• Hamilton Depression Rating Scale (HAMD) score

  Baseline, 3-month follow-up and 6-month follow-up

• Hamilton Anxiety Rating Scale (HAMA) score

  Baseline, 3-month follow-up and 6-month follow-up

Study Arms (2)

Treatment group

EXPERIMENTAL

Drug: Getong Tongluo Capsule; Drug: Standard Routine Therapy for Ischemic Stroke

Placebo group

PLACEBO COMPARATOR

Other: Matched Starch Placebo Capsule; Drug: Standard Routine Therapy for Ischemic Stroke

Interventions

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.

Treatment group

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.

Placebo group

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.

Placebo group; Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: July 8, 2026

Record last verified: 2026-07