Yiqi Huayu Jiedu Therapy for Non-Surgical Supratentorial Hypertensive Intracerebral Hemorrhage (CHAIN2)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Lijin Huang, Professor
- Número de telefone: 13802990238
- E-mail: hlj193@139.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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:
- 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.
- 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.
- 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.
- 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.
- Known allergy to any traditional Chinese medicine component of the mixture.
- Pregnant or lactating women.
- Participation in another clinical trial that may interfere with the evaluation of this study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Yiqi Huayu Jiedu Mixture Intervention Group
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Yiqi Huayu Jiedu Mixture, composed of red ginseng, Panax notoginseng, and raw rhubarb
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Comparador de Placebo: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
the favorable prognosis rate
Prazo: at 180 days
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mRS 0-2
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at 180 days
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Ordinal mRS outcome data
Prazo: at 28, 90, and 180 days
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at 28, 90, and 180 days
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NIHSS scores
Prazo: at 7, 14, and 28 days
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at 7, 14, and 28 days
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EQ-5D-5L scores
Prazo: at 28, 90, and 180 days
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at 28, 90, and 180 days
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Hematoma volume and perihematomal edema volume
Prazo: at 7 days, 14 days, or discharge.
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at 7 days, 14 days, or discharge.
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GCS score
Prazo: at days 7, 14, and 28
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at days 7, 14, and 28
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Wu B, Liu M, Liu H, Li W, Tan S, Zhang S, Fang Y. Meta-analysis of traditional Chinese patent medicine for ischemic stroke. Stroke. 2007 Jun;38(6):1973-9. doi: 10.1161/STROKEAHA.106.473165. Epub 2007 Apr 26.
- Wan Y, Holste KG, Hua Y, Keep RF, Xi G. Brain edema formation and therapy after intracerebral hemorrhage. Neurobiol Dis. 2023 Jan;176:105948. doi: 10.1016/j.nbd.2022.105948. Epub 2022 Dec 5.
- Ma L, Hu X, Song L, Chen X, Ouyang M, Billot L, Li Q, Malavera A, Li X, Munoz-Venturelli P, de Silva A, Thang NH, Wahab KW, Pandian JD, Wasay M, Pontes-Neto OM, Abanto C, Arauz A, Shi H, Tang G, Zhu S, She X, Liu L, Sakamoto Y, You S, Han Q, Crutzen B, Cheung E, Li Y, Wang X, Chen C, Liu F, Zhao Y, Li H, Liu Y, Jiang Y, Chen L, Wu B, Liu M, Xu J, You C, Anderson CS; INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet. 2023 Jul 1;402(10395):27-40. doi: 10.1016/S0140-6736(23)00806-1. Epub 2023 May 25.
- Zhai Z, Su PW, Ma LY, Yang H, Wang T, Fei ZG, Zhang YN, Wang Y, Ma K, Han BB, Wu ZC, Yu HY, Zhao HJ. Progress on traditional Chinese medicine in treatment of ischemic stroke via the gut-brain axis. Biomed Pharmacother. 2023 Jan;157:114056. doi: 10.1016/j.biopha.2022.114056. Epub 2022 Nov 26.
- Pradilla G, Ratcliff JJ, Hall AJ, Saville BR, Allen JW, Paulon G, McGlothlin A, Lewis RJ, Fitzgerald M, Caveney AF, Li XT, Bain M, Gomes J, Jankowitz B, Zenonos G, Molyneaux BJ, Davies J, Siddiqui A, Chicoine MR, Keyrouz SG, Grossberg JA, Shah MV, Singh R, Bohnstedt BN, Frankel M, Wright DW, Barrow DL; ENRICH trial investigators; ENRICH Trial Investigators. Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med. 2024 Apr 11;390(14):1277-1289. doi: 10.1056/NEJMoa2308440.
- Seiffge DJ, Anderson CS. Treatment for intracerebral hemorrhage: Dawn of a new era. Int J Stroke. 2024 Jun;19(5):482-489. doi: 10.1177/17474930241250259.
Datas de registro do estudo
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Conclusão do estudo (Estimado)
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Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BF2026-084-01
- 2026ZD0555303 (Número de outro subsídio/financiamento: Development Center for Medical Science and Technology, National Health Commission)
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