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

ShuGuang Hospital

Status and phase: Unknown; Phase 4

Conditions: Hemorrhagic Stroke

Treatments: Drug: Placebo; Drug: Granules of Shengdi Dahuang Decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT04200781

19401972800

Details and patient eligibility

About

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.

Full 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.

Enrollment: 464 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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464 participants in 2 patient groups, including a placebo group

Shengdi Dahuang Decoction

Experimental group

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.

Treatment:

Drug: Granules of Shengdi Dahuang Decoction

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo