The purpose of this study is to assess the efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project.
The main purpose of the study is to observe the clinical efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke. This project is funded by Science and Technology Commission of Shanghai Municipality and will be carried out in 5 hospitals. Investigators will recruit 464 participants who meet the inclusion criteria and agree to participate in the research. Participants will be randomly assigned into experimental or placebo group. Granules of Shengdi Decoction is the therapeutic drug used in the experimental group. Each pack of the test drug contains 15 grams of rehmannia and 5 grams of rhubarb. While for the placebo group, each pack contains 2% rehmannia and rhubarb. Participants will receive a follow-up observation in the following 90 days. Modified Rankin Scale score (mRS), the mortality rate on day 7 and day 90 after treatment, National Institute of Health Stroke Scale (NIHSS), expansion rate of hematoma, the degree of edema and the expressions of inflammatory indicators will be detected to evaluate the clinical efficacy of Shengdi Dahuang Decoction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
464
Shengdi Dahuang Decoction contains Shengdi (rehmannia) and Dahuang ( rhubarb). Each pack of the granules of Shengdi Dahuang Decoction contains 15 grams of rehmannia and 5 grams of rhubarb.
Placebo granules has the same appearence, weight, shape and color as the experimental drug.
Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Disability rate
Modified Rankin Scale score (mRS) will be graded on the 90th day after onset (mRS score ranges from 0 point (no symptoms at all) to 5 points (severe disability)).
Time frame: 90 days
Mortality rate on the 7th day
The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.
Time frame: 7 days
Mortality rate on the 90th day
The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.
Time frame: 90 days
Severity of neurological deficit
National Institute of Health Stroke Scale (NIHSS) will be used to assess the severity of neurological deficit on the 7th day after treatment. NIHSS score ranges from 0 point to 42 points. More severe neurological deficit could be observed in participants with the higher score.
Time frame: 7 days
The proportion of hematoma enlargement cases
All participants will reexamine the skull CT scan 24 hours after onset. The volume of hematoma (ml) increases more than 6ml or 33% relative increment than original volume is defined as the expansion of hematoma. The proportion of hematoma enlargement cases (%) will be compared between different groups.
Time frame: 24 hours
Severity of edema
All participants will reexamine the skull CT scan on the 7th day after treatment. The volume (ml) of edema and hematoma will be calculated respectively. The ratio of edema volume and hematoma volume represents the severity of edema.
Time frame: 7 days
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Shanghai, Shanghai Municipality, China
Shuguang Hospital affiliated with Shanghai University of TCM
Shanghai, Shanghai Municipality, China
RECRUITINGYueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
RECRUITING