Clinical trial NCT04200781: Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke
Official title: A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemorrhagic Stroke
Keywords: acute hemorrhagic stroke
Shengdi Dahuang Decoction
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of acute intracerebral hemorrhage；
2. CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is \<80ml;
3. The time from onset to confirmed diagnosis by CT scan is within 4 hours;
4. Enrolled and receive treatment within 12 hours from onset;
5. Age ≥18 years old;
6. Obtain approval from the patient or family members.

Exclusion Criteria:

1. The time from onset to confirmed diagnosis by CT scan is over 4 hours;
2. CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one);
3. The volume of hematoma is above 80ml;
4. Glasgow Coma Scale (GCS) is ≤ 5 points;
5. The time from onset to confirmed diagnosis is over 12 hours;
6. Have a surgical treatment planning within 24 hours;
7. Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;
8. Patients with disabilities before onset (modified mRS score \> 2);
9. Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;
10. Patients who have participated in other clinical trials within the past 1 month;
11. Pregnant or nursing women;
12. Allergic constitution (allergic to more than two kinds of food or medications).

Primary outcomes:
measure: Disability rate
timeFrame: 90 days
measure: Mortality rate on the 7th day
timeFrame: 7 days
Secondary outcomes:
measure: Mortality rate on the 90th day
timeFrame: 90 days
measure: Severity of neurological deficit
timeFrame: 7 days
measure: The proportion of hematoma enlargement cases
timeFrame: 24 hours
measure: Severity of edema
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital affiliated with Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shuguang Hospital affiliated with Shanghai University of TCM
name: Xiaofei Yu
role: STUDY_CHAIR
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