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

December 13, 2019 updated by: Xiaofei Yu, ShuGuang Hospital

A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

464

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shuguang Hospital Affiliated with Shanghai University of TCM
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Chinese Herbal Compound
Placebo Comparator: 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.
Drug: Placebo
Placebo granules has the same appearence, weight, shape and color as the experimental drug.
Other Names:
  • Placebo of Chinese Herbal Compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability rate
Time Frame: 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)).
90 days
Mortality rate on the 7th day
Time Frame: 7 days
The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate on the 90th day
Time Frame: 90 days
The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.
90 days
Severity of neurological deficit
Time Frame: 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.
7 days
The proportion of hematoma enlargement cases
Time Frame: 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.
24 hours
Severity of edema
Time Frame: 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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShuGuang Hospital

Investigators

  • Study Chair: Xiaofei Yu, Shuguang Hospital Affiliated with Shanghai University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19401972800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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