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

Hemorrhagic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04200781
• Other study ID #: 19401972800
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2019
• Source: ShuGuang Hospital
• Contact: Xiaoyu Yu
• Phone: 86-021-20256378
• Email: doctorxiaoyu[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 464
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Intracranial Hemorrhages
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University	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

Sponsors (1)

Lead Sponsor	Collaborator
ShuGuang Hospital

Country where clinical trial is conducted

China, 

References & Publications (21)

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Cai M, Yu Z, Zhang W, Yang L, Xiang J, Zhang J, Zhang Z, Wu T, Li X, Fu M, Bao X, Yu X, Cai D. Sheng-Di-Da-Huang Decoction Inhibited Inflammation Expressed in Microglia after Intracerebral Hemorrhage in Rats. Evid Based Complement Alternat Med. 2018 Oct 1 — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mortality rate on the 90th day	The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.	90 days
Secondary	Severity of neurological deficit	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
Secondary	The proportion of hematoma enlargement cases	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
Secondary	Severity of edema	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