Ischemic Stroke, AcuteNCT07690020
Clinical Efficacy and Mechanism Research of Getong Tongluo Capsule in Ischemic Stroke
A study testing Getong Tongluo Capsule and Standard Routine Therapy for Ischemic Stroke in people with Ischemic Stroke, Acute, run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Getong Tongluo Capsule and Standard Routine Therapy for Ischemic Stroke
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
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
- Being tested
- Getong Tongluo Capsule, Matched Starch Placebo Capsule, Standard Routine Therapy for Ischemic Stroke
- Keywords
- Post-acute Ischemic Stroke, Ischemic Stroke, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Getong Tongluo CapsuleDrug
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 CapsuleOther
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 StrokeDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Getong Tongluo Capsule; Drug: Standard Routine Therapy for Ischemic Stroke |
| Placebo group | Placebo comparator | Not described Receives: Other: Matched Starch Placebo Capsule; Drug: Standard Routine Therapy for Ischemic Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of modified Rankin Scale (mRS) scores
Scores range from 0 (no symptoms) to 6 (death); higher scores indicate poorer functional recovery
Measured: Baseline, 3-month follow-up and 6-month follow-up
Incidence of adverse events
Measured: Through study completion, an average of 6 months
Secondary outcomes (8)
Athens Insomnia Scale (AIS) score
Total score ranges from 0 to 24; higher scores indicate more severe insomnia (worse sleep condition)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 3-month follow-up and 6-month follow-up
Incidence rate of drug-related adverse reactions
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690020
- Sponsor's protocol ID
- NFEC-2026-409
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No