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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

464

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Sep 2019

Typical duration for phase_4

Geographic Reach

1 country

5 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

September 1, 2019

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed

10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed

Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

December 6, 2019

Last Update Submit

December 13, 2019

Conditions

Hemorrhagic Stroke

Keywords

acute hemorrhagic strokeShengdi Dahuang Decoction

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (4)

Mortality rate on the 90th day
90 days
Severity of neurological deficit
7 days
The proportion of hematoma enlargement cases
24 hours
Severity of edema
7 days

Study Arms (2)

Shengdi Dahuang Decoction

EXPERIMENTAL

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.

Drug: Granules of Shengdi Dahuang Decoction

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Granules of Shengdi Dahuang DecoctionDRUG

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.

Also known as: Chinese Herbal Compound

Shengdi Dahuang Decoction

PlaceboDRUG

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

Also known as: Placebo of Chinese Herbal Compound

Placebo

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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).

Contact the study team to confirm eligibility.