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Can a herbal formula match traditional medicine for brain bleeds?

NCT ID NCT07801599

Disease control Sponsor: Guangzhou University of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether a granule form of the Chinese herbal formula Huayu Jiedu (FTFY-919) works as well as the traditional decoction for people with acute hypertensive intracerebral hemorrhage, a type of stroke caused by bleeding in the brain. About 300 adults who have had a brain bleed within the past 48 hours will receive either the granules, the traditional decoction, or a placebo for 28 days, alongside standard care. The main goal is to compare the granules to the decoction in terms of recovery and disability at 90 days, with a placebo group as a reference. The study will also track neurological function, bleeding size, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Huayu Jiedu Formula (FTFY-919) granules, a Chinese medicine formula containing red ginseng, notoginseng, and rhubarb
What this could lead to
If the granules match the traditional decoction's effects, patients could get a more convenient, standardized treatment for bleeding in the brain after a stroke.
What could go wrong
This is an early-stage test in 300 people, and the granules might not prove as effective as hoped. The trial also focuses on a specific type of brain bleed, so results may not apply to all stroke patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 40 years; * Spontaneous intracerebral hemorrhage (ICH) confirmed by neuroimaging; * Hematoma volume 15-60 mL; * Within 48 hours of symptom onset (if onset time is unknown, the time last seen normal is used); * Meeting one of the following: basal ganglia or lobar hemorrhage with NIHSS score ≥ 8; or thalamic, brainstem or cerebellar hemorrhage with Glasgow Coma Scale (GCS) score 7-14; * Written informed consent obtained from the patient or the legal representative. Exclusion Criteria: * ICH secondary to structural brain abnormalities (including but not limited to cerebral vascular malformation, intracranial aneurysm, malignant tumor, moyamoya disease, trauma and prior ischemic stroke), cerebral amyloid angiopathy, thrombolysis or thrombectomy, anticoagulant therapy, antiplatelet therapy, or other secondary causes; * Patients judged by the responsible physician unlikely to benefit from the trial (e.g., advanced dementia) or at very high risk of early death, or other conditions considered unsuitable by the investigator; * Conditions that may interfere with follow-up or outcome assessment (e.g., significant pre-stroke disability with modified Rankin Scale score 3-5, end-stage malignant tumor, renal failure); * Known contraindications to Chinese medicine; * Pregnancy or breastfeeding; * Participation in another clinical trial that may interfere with the evaluation of this trial.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder intracerebral hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Intracerebral hemorrhage

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