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Yiqi Huayu Jiedu Therapy for Non-Surgical Supratentorial Hypertensive Intracerebral Hemorrhage (CHAIN2)

11. mai 2026 oppdatert av: jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine

Clinical Study of Yiqi Huayu Jiedu Therapy in Non-Surgical Patients With Supratentorial Hypertensive Intracerebral Hemorrhage

This multicenter, prospective, double-blind, randomized controlled trial will enroll 902 non-surgical patients with supratentorial hypertensive intracerebral hemorrhage who meet the traditional Chinese medicine syndrome criteria of Qi deficiency with blood stasis and toxin-induced injury to the brain collaterals.

The primary efficacy endpoint is the proportion of patients achieving a favorable outcome, defined as a modified Rankin Scale score of 0-2 at 180 days after treatment. Participants will be allocated across three trial regions: South China, Northeast China, and East China, with target enrollments of 400, 300, and 202 patients, respectively. Using a central randomization system, patients will be stratified by study center, hematoma volume, and severity of neurological deficit, and randomized 1:1 to the experimental group or control group.

The experimental group will receive Yiqi Huayu Jiedu Mixture, composed of red ginseng, Panax notoginseng, and raw rhubarb, while the control group will receive a matching placebo. Both interventions will be administered for 28 days, in addition to standardized conventional Western medical treatment.

Clinical and imaging data will be collected at multiple time points throughout the study. The primary outcome is the favorable prognosis rate at 180 days. Secondary outcomes include neurological function, quality of life, hematoma and perihematomal edema volume, and other relevant indicators. Adverse events will be monitored to evaluate the safety and efficacy of the mixture in reducing mortality and disability among patients with hypertensive intracerebral hemorrhage.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

902

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Lijin Huang, Professor
  • Telefonnummer: 13802990238
  • E-post: hlj193@139.com

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.Adults aged 18 years or older, with no restriction on sex. 2.6 to 48 hours after symptom onset; if the exact onset time cannot be determined, the time shall be calculated from the last known well.

3.Patients meeting the traditional Chinese medicine syndrome criteria of "Qi deficiency, blood stasis, and toxin-induced injury to the brain collaterals." Diagnosis shall be based on the Expert Consensus on Integrated Traditional Chinese and Western Medicine for Cerebral Hemorrhage (T/CAIM 023-2021) issued by the Chinese Association of Integrative Medicine.

4.Imaging-confirmed supratentorial hypertensive intracerebral hemorrhage (HICH) located in the basal ganglia, thalamus, lobar region, or subcortical white matter, with a hematoma volume of 15-60 mL.

5.NIHSS score ≥ 8 and GCS score > 7. 6.The patient or the patient's legally authorized representative has provided written informed consent

Exclusion Criteria:

Patients meeting **one or more** of the following criteria will be excluded:

  1. Intracerebral hemorrhage secondary to structural brain abnormalities, including but not limited to cerebral vascular malformation, intracranial aneurysm, malignant tumor, moyamoya disease, trauma, previous ischemic stroke, cerebral amyloid angiopathy, thrombolysis or thrombectomy, anticoagulant therapy, or other causes of secondary intracerebral hemorrhage.
  2. Patients who, in the judgment of the treating physician, are unlikely to benefit from the trial, have an extremely high risk of early death, or are considered unsuitable for participation by the investigator, such as patients with advanced dementia.
  3. Conditions that may interfere with follow-up or outcome assessment, such as known significant pre-stroke disability, modified Rankin Scale score of 3-5, end-stage malignancy, or renal failure.
  4. Indications for decompressive craniectomy, including but not limited to coma or progressive deterioration of consciousness, large hematoma with significant midline shift, intracranial hypertension difficult to control with medical treatment, cerebral herniation or impending herniation, or marked mass effect on imaging, such as midline shift >10 mm or compression/disappearance of cisterns or sulci.
  5. Known allergy to any traditional Chinese medicine component of the mixture.
  6. Pregnant or lactating women.
  7. Participation in another clinical trial that may interfere with the evaluation of this study.

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Yiqi Huayu Jiedu Mixture Intervention Group
Yiqi Huayu Jiedu Mixture, composed of red ginseng, Panax notoginseng, and raw rhubarb
Placebo komparator: Placebo Comparator Group
The placebo is matched to the Yiqi Huayu Jiedu mixture in terms of outer packaging, appearance, odor, taste, and other identifiable characteristics to ensure blinding.
The placebo is matched to the Yiqi Huayu Jiedu mixture in terms of outer packaging, appearance, odor, taste, and other identifiable characteristics to ensure blinding.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
the favorable prognosis rate
Tidsramme: at 180 days
mRS 0-2
at 180 days

Sekundære resultatmål

Resultatmål
Tidsramme
Ordinal mRS outcome data
Tidsramme: at 28, 90, and 180 days
at 28, 90, and 180 days
NIHSS scores
Tidsramme: at 7, 14, and 28 days
at 7, 14, and 28 days
EQ-5D-5L scores
Tidsramme: at 28, 90, and 180 days
at 28, 90, and 180 days
Hematoma volume and perihematomal edema volume
Tidsramme: at 7 days, 14 days, or discharge.
at 7 days, 14 days, or discharge.
GCS score
Tidsramme: at days 7, 14, and 28
at days 7, 14, and 28

Samarbeidspartnere og etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

1. oktober 2028

Studiet fullført (Antatt)

1. februar 2030

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • BF2026-084-01
  • 2026ZD0555303 (Annet stipend/finansieringsnummer: Development Center for Medical Science and Technology, National Health Commission)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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