Intracerebral Hemorrhage
Conditions
Keywords
Activating blood stagnation and expelling blood stasis, Hematoma enlargement, herbal medicine, traditional chinese medicine, random clinical trial
Brief summary
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.
Detailed 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.
Interventions
DRUGICH-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
DRUGplacebo
placebo herbal medicine, one dose,bid, for 10 days
DRUGICH-2(herbal medicine without Hirudo, Tabanus)
(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematoma enlargement | 24hrs, 10-14days |
Secondary
| Measure | Time frame |
|---|---|
| fatality rate | 3 month |
| modified rankin scale | 3 months |
| National Institute of Health of stroke scale | 10-14days, 90days |
Countries
China
Outcome results
None listed