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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ICH-1

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

Group Type EXPERIMENTAL

ICH-1(herbal medicine with Hirudo, Tabanus)

Intervention Type DRUG

8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days

ICH-2

herbal medicine without Hirudo, Tabanus,Only 6 herbals

Group Type ACTIVE_COMPARATOR

ICH-2(herbal medicine without Hirudo, Tabanus)

Intervention Type DRUG

(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days

placebo herbal medicine

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo herbal medicine, one dose,bid, for 10 days

Interventions

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ICH-1(herbal medicine with Hirudo, Tabanus)

8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days

Intervention Type DRUG

placebo

placebo herbal medicine, one dose,bid, for 10 days

Intervention Type DRUG

ICH-2(herbal medicine without Hirudo, Tabanus)

(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days

Intervention Type DRUG

Other Intervention Names

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PXZY pxzyp NPXZY

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No