NCT07690020Not yet recruiting
Clinical Efficacy and Mechanism Research of Getong Tongluo Capsule in Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Stroke
- NCT number
- NCT07690020
What you commit to
- Study type: Interventional
- Planned participants: 216
- From 1 Aug 2026 to the primary completion date, 31 Jul 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 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.
Other illness
- 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 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 with a history of allergy to the study drug or preparations with identical active ingredients.
Other
- 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).
- Pregnant and lactating women.
- Patients deemed unsuitable for participation in this trial at the investigator's discretion.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.