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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
placebo herbal medicine, one dose,bid, for 10 days
(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangzhou Hospital of Integrated traditional and west medicine
Guangzhou, Guangdong, China
Panyu Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Boluo County People's Hospital
Huizhou, Guangdong, China
Jiangmen Wuyi Traditional Chinese Medicine Hospital
Jiangmen, Guangdong, China
The hospital of Chinese Medicine of Conghua City
Jiekou, Guangdong, China
Lianjiang People's hospital
Lianjiang, Guangdong, China
Zengcheng City Hospital of traditional Chinese Medicine
Licheng, Guangdong, China
Boji-affiliated Hospital of Sun Yat-sen University
Licheng, Guangdong, China
...and 5 more locations
Hematoma enlargement
Time frame: 24hrs, 10-14days
fatality rate
Time frame: 3 month
modified rankin scale
Time frame: 3 months
National Institute of Health of stroke scale
Time frame: 10-14days, 90days
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