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NCT Number: NCT07580235

Yiqi Huayu Jiedu Therapy for Non-Surgical 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yiqi Huayu Jiedu Mixture Intervention

Drug

Yiqi Huayu Jiedu Mixture, composed of red ginseng, Panax notoginseng, and raw rhubarb

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.

Primary outcomes

  1. the favorable prognosis rate

    Time frame: at 180 days

    mRS 0-2

Secondary outcomes

  1. Ordinal mRS outcome data

    Time frame: at 28, 90, and 180 days

  2. NIHSS scores

    Time frame: at 7, 14, and 28 days

  3. EQ-5D-5L scores

    Time frame: at 28, 90, and 180 days

  4. Hematoma volume and perihematomal edema volume

    Time frame: at 7 days, 14 days, or discharge.

  5. GCS score

    Time frame: at days 7, 14, and 28

Study contacts

Contact information is provided by the study sponsor or research team.

Lijin Huang, Professor

CONTACT

[email protected]

13802990238

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Acronym: CHAIN2

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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