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NCT04200781

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

NCT ID: NCT04200781

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Hemorrhagic Stroke

Keywords

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acute hemorrhagic stroke Shengdi Dahuang Decoction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Granules of Shengdi Dahuang Decoction

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo granules has the same appearence, weight, shape and color as the experimental drug.

Interventions

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Granules of Shengdi Dahuang Decoction

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

Placebo

Placebo granules has the same appearence, weight, shape and color as the experimental drug.

Intervention Type DRUG

Other Intervention Names

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Chinese Herbal Compound Placebo of Chinese Herbal Compound

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Xiaofei Yu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofei Yu

Role: STUDY_CHAIR

Shuguang Hospital affiliated with Shanghai University of TCM

Locations

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