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| ID | Type | Description | Link |
|---|---|---|---|
| 2026ZD0555303 | Other Grant/Funding Number | Development Center for Medical Science and Technology, National Health Commission |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yiqi Huayu Jiedu Mixture Intervention Group | Experimental |
| |
| Placebo Comparator Group | Placebo Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yiqi Huayu Jiedu Mixture Intervention | Drug | Yiqi Huayu Jiedu Mixture, composed of red ginseng, Panax notoginseng, and raw rhubarb |
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| Measure | Description | Time Frame |
|---|---|---|
| the favorable prognosis rate | mRS 0-2 | at 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal mRS outcome data | at 28, 90, and 180 days | |
| NIHSS scores | at 7, 14, and 28 days | |
| EQ-5D-5L scores |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lijin Huang, Professor | Contact | 13802990238 | hlj193@139.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17463317 | Result | 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. | |
| 36481437 | Result | 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. |
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| ID | Term |
|---|---|
| D020299 | Intracranial Hemorrhage, Hypertensive |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Participants will be randomly assigned in a parallel manner to 2 arms: an experimental group and a placebo control group. This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical study.
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| The placebo | Drug | 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. |
|
| at 28, 90, and 180 days |
| Hematoma volume and perihematomal edema volume | at 7 days, 14 days, or discharge. |
| GCS score | at days 7, 14, and 28 |
| 37245517 | Result | 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. |
| 36446240 | Result | 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. |
| 38598795 | Result | 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. |
| 34487721 | Result | 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. |
| 38803115 | Result | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |