Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke
Primary Purpose
Hemorrhagic Stroke
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Granules of Shengdi Dahuang Decoction
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Stroke focused on measuring acute hemorrhagic stroke, Shengdi Dahuang Decoction
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria of acute intracerebral hemorrhage;
- CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml;
- The time from onset to confirmed diagnosis by CT scan is within 4 hours;
- Enrolled and receive treatment within 12 hours from onset;
- Age ≥18 years old;
- Obtain approval from the patient or family members.
Exclusion Criteria:
- The time from onset to confirmed diagnosis by CT scan is over 4 hours;
- 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);
- The volume of hematoma is above 80ml;
- Glasgow Coma Scale (GCS) is ≤ 5 points;
- The time from onset to confirmed diagnosis is over 12 hours;
- Have a surgical treatment planning within 24 hours;
- Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;
- Patients with disabilities before onset (modified mRS score > 2);
- Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;
- Patients who have participated in other clinical trials within the past 1 month;
- Pregnant or nursing women;
- Allergic constitution (allergic to more than two kinds of food or medications).
Sites / Locations
- Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCMRecruiting
- Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong UniversityRecruiting
- Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji UniversityRecruiting
- Shuguang Hospital affiliated with Shanghai University of TCMRecruiting
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Shengdi Dahuang Decoction
Placebo
Arm Description
To clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.
To explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.
Outcomes
Primary Outcome Measures
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)).
Mortality rate on the 7th day
The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.
Secondary Outcome Measures
Mortality rate on the 90th day
The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04200781
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke
Keywords
acute hemorrhagic stroke, Shengdi Dahuang Decoction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
464 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shengdi Dahuang Decoction
Arm Type
Experimental
Arm Description
To clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
To explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Granules of Shengdi Dahuang Decoction
Other Intervention Name(s)
Chinese Herbal Compound
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo of Chinese Herbal Compound
Intervention Description
Placebo granules has the same appearence, weight, shape and color as the experimental drug.
Primary Outcome Measure Information:
Title
Disability rate
Description
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
Title
Mortality rate on the 7th day
Description
The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Mortality rate on the 90th day
Description
The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.
Time Frame
90 days
Title
Severity of neurological deficit
Description
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
Title
The proportion of hematoma enlargement cases
Description
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
Title
Severity of edema
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the diagnostic criteria of acute intracerebral hemorrhage;
CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml;
The time from onset to confirmed diagnosis by CT scan is within 4 hours;
Enrolled and receive treatment within 12 hours from onset;
Age ≥18 years old;
Obtain approval from the patient or family members.
Exclusion Criteria:
The time from onset to confirmed diagnosis by CT scan is over 4 hours;
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);
The volume of hematoma is above 80ml;
Glasgow Coma Scale (GCS) is ≤ 5 points;
The time from onset to confirmed diagnosis is over 12 hours;
Have a surgical treatment planning within 24 hours;
Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;
Patients with disabilities before onset (modified mRS score > 2);
Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;
Patients who have participated in other clinical trials within the past 1 month;
Pregnant or nursing women;
Allergic constitution (allergic to more than two kinds of food or medications).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyu Yu
Phone
86-021-20256378
Email
doctorxiaoyu@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofei Yu
Organizational Affiliation
Shuguang Hospital affiliated with Shanghai University of TCM
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Phone
+86-13816566556
Email
13816566556@163.com
Facility Name
Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyan Xiang
Phone
86-18930173850
Email
xiang_jing_yan@aliyun.com
Facility Name
Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyu Zhou
Phone
86-18049929570
Email
13564532819@163.com
Facility Name
Shuguang Hospital affiliated with Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Yu
Phone
86-13331978806
Email
doctorxiaoyu@sina.com
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Han
Phone
86-13917022800
Email
hanyan.2006@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke
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