Clinical Re-evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

Guangzhou University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 4

Conditions: Intracerebral Hemorrhage

Treatments: Drug: ICH-1(herbal medicine with Hirudo, Tabanus); Drug: placebo; Drug: ICH-2(herbal medicine without Hirudo, Tabanus)

Study type: Interventional

Funder types: Other

Identifiers

NCT01918722

JDZX2012074 (Other Grant/Funding Number)

Details and patient eligibility

About

In order to investigate the time window of acute intracerebral hemorrhage(AICH) by "Blood Activating and Stasis Dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the therapy lasts two weeks, and the follow up should last three months. The main indexes are mortality rate, disability rate and the brain hematoma situation. The review is made by the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.

Full description

objective: to investigate the safety and effect of acute cerebral hemorrhage treated with "Blood Activating and Stasis Dispersing" therapy and to verify the traditional methods can influence the brain hematoma enlargement or not.

Methods: from 2013.8 to 2015.12, 360 cases of AICH will be included in 13 research centers. Patients are randomly into 3 groups within 6hrs from onset,such as, group A, blood activating herbal medicine (8 herbals), Group B, herbal medicine without blood activating herbal(6 herbals), Group C, placebo for 10days. All the patients will be treated according AHA guideline of AICH. All patients will be set to the CT at the onset, 24h later and 10-14days after treatment. So the rate of enlargement of brain hematoma in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• no younger than 18 yrs
• acute cerebral hemorrhage confirmed by brain CT scan
• within 6 hours from onset
• GCS≥6
• Sign the informed consent form

Exclusion criteria

• Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc;
• patients with Severe heart, liver and renal insufficiency.
• Intolerance to traditional Chinese medicine (TCM), allergic constitution.
• patients with severe cerebral hernia in the early onset
• Compliance is poor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups, including a placebo group

ICH-1

Experimental group

Description:

herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function

Treatment:

Drug: ICH-1(herbal medicine with Hirudo, Tabanus)

ICH-2

Active Comparator group

Description:

herbal medicine without Hirudo, Tabanus,Only 6 herbals

Treatment:

Drug: ICH-2(herbal medicine without Hirudo, Tabanus)

placebo herbal medicine

Placebo Comparator group

Description:

Placebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days

Treatment:

Drug: placebo