Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

Traditional Chinese Medicine Clinical Trial

— CERBSTTSCH  

Official title:

Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03354026
• Other study ID #: JDZX2015048
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 10, 2017
• Last updated: November 23, 2017
• Start date: November 2017
• Est. completion date: December 2022

Study information

• Verified date: November 2017
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Jianwen J Guo, Doctor
• Phone: +86 13724899379
• Email: jianwen_guo[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to use the "Removing Blood Stasis Decotion" of traditional Chinese medicine treating the acute stage of cerebral hemorrhage with stroke associated pneumonia to explore the impact of "Removing Blood Stasis Therapy" on intestinal microbial flora either within the time window from 6 to 72 hours onset.

Description:

objective: to investigate the impact and immunologic mechanism of using the "Removing Blood Stasis Decotion" treatment in SAP after Acute Cerebral Hemorrhage with the concept of Intestinal Micro Ecological Regulation.

Methods: from 2017.01 to 2022.12, 240 cases of AICH, 306 cases of hypertension will be included in 7 research centers. The AICH patients are randomly into 3 groups within 6 to 72hrs from onset, thus there are 3 groups and the treatment will last for 10 days: group A，Removing Blood Stasis herbal medicine(8 herbals); Group B, herbal medicine without Poxuezhuyu activating herbal(6 herbals); Group C, placebo medicine of Chinese medicine.All the patients will be treated according AHA guideline of AICH and will be set to the brain CT and chest X-ray at the onset, 24h later and 10-14days after treatment. The venous blood，feces Specimen and the sputum will be collected in the time point of 6 to 72hrs within onset , 24h later, and 10-14days after treatment.So the rate of enlargement of brain hematoma and the development of SAP in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 306
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Greater than or equal to 18 years old while younger than 80 years old

• acute cerebral hemorrhage confirmed by brain CT scan within 6 to72 hours from onset

• GCS=6

• Sign the informed consent form

Exclusion Criteria:

• Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc;

• patients with Severe heart, liver and renal insufficiency.

• Intolerance to traditional Chinese medicine (TCM), allergic constitution.

• patients with severe cerebral hernia in the early onset

• Compliance is poor.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage, Hypertensive
• Intracranial Hemorrhage, Hypertensive
• Traditional Chinese Medicine

Intervention

Drug:
• AICH-PXZY
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
• AICH-without PXZY
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
• AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Guangdong Provincial Science and Technology Agency	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Lianjiang people's Hospital, Liaocheng People's Hospital, Shenyang Second Hospital of traditional Chinese Medicine, Shouguang people's Hospital, The third people's Hospital of Hubei Province, Zengcheng Hospital of traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma enlargement	The hematoma volume enlarged 33% or increased 12.5ml defined as hematoma enlargement which are compared with the two CT scans(6-72h within onset and 24h after onset,or 6-72h within onset and 10-14days)	6-72h within onset, 24hrs, 10-14days
Secondary	GCS scoring scale	The Glasgow score was used to assess the coma index.	6-72hours within onset, 24hours later, 3 months
Secondary	National Institute of Health of stroke scale	The NIHSS is for evaluation of neurological deficits.	6-72hours within onset, 24hours later, 3 months
Secondary	BI index	BI index <90 defines life cannot be independent. The percentage of BI 100-90 points in the three groups was statistically followed up by 90ds.	3 months
Secondary	Social function activity questionnaire(FAQ)	FAQ is mainly to know the quality of life and living habits of the patients and their families.	3 months
Secondary	fatality rate	Any cause of death within the entire treatment 10ds and follow-up 90ds.	3 months
Secondary	modified rankin scale	Scoring 2-5 is defined as disability, which can be divided into 4 grades: mild, moderate, severe and severe. The percentage of mRS 0-1 points in the three groups will be statistically followed up by 90ds.	3 months