Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

Phase 4

• Conditions: Hemorrhagic Stroke
• Interventions: Drug: Granules of Shengdi Dahuang Decoction; Drug: Placebo

• Registration Number: NCT04200781
• Lead Sponsor: ShuGuang Hospital

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.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-13
• Study First Posted: 2019-12-16
• Last Update Posted: 2019-12-16
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 464

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shengdi Dahuang Decoction	Granules of Shengdi Dahuang Decoction	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Disability rate	90 days	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	7 days	The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.

Secondary Outcome Measures

Name	Time	Method
Mortality rate on the 90th day	90 days	The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.
Severity of neurological deficit	7 days	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	24 hours	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	7 days	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.

Trial Locations

Locations (5)

Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China

Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University; 🇨🇳 Shanghai, Shanghai, China

Shuguang Hospital affiliated with Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China