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

7. juli 2026 oppdatert av: Nanfang Hospital, Southern Medical University
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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

216

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Behandlingsgruppe
Legemiddel: 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.
Legemiddel: 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 komparator: Placebo gruppe
Legemiddel: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of modified Rankin Scale (mRS) scores
Tidsramme: 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
Baseline, 3-month follow-up and 6-month follow-up
Incidence of adverse events
Tidsramme: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Athens Insomnia Scale (AIS) score
Tidsramme: 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)
Baseline, 3-month follow-up and 6-month follow-up
Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement
Tidsramme: 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.
Baseline, 3-month follow-up and 6-month follow-up
Activities of Daily Living (ADL) score
Tidsramme: Baseline, 3-month follow-up and 6-month follow-up
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
Tidsramme: Baseline, 3-month follow-up and 6-month follow-up
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
Tidsramme: Baseline, 3-month follow-up and 6-month follow-up
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
Tidsramme: Baseline, 3-month follow-up and 6-month follow-up
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
Tidsramme: Baseline, 3-month follow-up and 6-month follow-up
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
Tidsramme: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nanfang Hospital, Southern Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

31. juli 2029

Studiet fullført (Antatt)

31. januar 2030

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

8. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NFEC-2026-409

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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