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A Study to Evaluate the Efficacy of Zhilong Huoxue Tongyu Capsules in Patients in the Recovery Phase of Intracerebral Hemorrhage

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Zhilong Huoxue Tongyu Capsules in the Treatment of Patients in the Recovery Phase of Intracerebral Hemorrhage.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000333
Enrollment
Unknown
Registered
2024-08-31
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Interventions

control group:The control group will receive the basic treatment plan plus a placebo, [taken orally, three capsules (1.05g) each time, three times a day, for a continuous period of 28 days]. The speci
experimental group:The experimental group will receive the basic treatment plan plus Zhilong Huoxue Tongyu Capsules
[taken orally, three capsules (1.05g) each time, three times a day, for a continuous period of 28 days.Developed based on the "Guidelines for the Diagnosis and Treatment of Intracerebral Hemorrhage in

Sponsors

The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis must meet the criteria for recovery from cerebral hemorrhage in Western medicine, with the onset of the condition between 2 weeks and 2 months. 2.Location of hemorrhage: Supratentorial or basal ganglia regions, and the hematoma has not ruptured into the ventricles. 3.Hemorrhage volume: Less than 30 ml. 4.Age of onset: Between 40 and 75 years old (inclusive). 5.First occurrence of the disease or previous history of stroke (ischemic or hemorrhagic) without residual sequelae. 6.No severe functional impairment of the heart, liver, kidneys, blood system, etc. 7.The patient and/or authorized representative must provide informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Secondary intracerebral hemorrhage due to various causes (including ruptured intracranial aneurysm, arteriovenous malformation or tumor bleeding, drug-related cerebral hemorrhage, etc.), subarachnoid hemorrhage, mixed stroke, multifocal hemorrhage, brain herniation, midline structure displacement greater than 5 mm, compression and obstruction of the same-sided lateral ventricle exceeding 1/2, and blurring or disappearance of the same-sided cistern and sulcus. 2.Gastrointestinal ulcers and individuals with a tendency to bleed. 3.Presence of severe complications, such as severe infections, coma, etc. 4.Bone and joint diseases, psychiatric disorders, severe dementia, etc., that affect clinical evaluation. 5.Pregnant or breastfeeding women. 6.Individuals allergic to the herbal components in this protocol. 7.Participants currently involved in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale;Barthel Index;Stroke Symptom Grading and Quantification Scale;National Institutes of Health Stroke Scale;

Countries

China

Contacts

Public ContactGang Liu

The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

1982luogang@163.com13679678969

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026