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

Phase 4

• Conditions: Intracerebral Hemorrhage, Hypertensive; Traditional Chinese Medicine
• Interventions: Drug: AICH-PXZY; Drug: AICH-without PXZY; Drug: AICH-placebo

• Registration Number: NCT03354026
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2017-11
• Study Start: 2017-11
• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-23
• Last Update Submitted: 2017-11-23
• Study First Posted: 2017-11-27
• Last Update Posted: 2017-11-27
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 306

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: AICH-PXZY	AICH-PXZY	Removing Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Experimental: AICH-without PXZY	AICH-placebo	Removing Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Placebo: AICH-placebo	AICH-without PXZY	The placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Experimental: AICH-PXZY	AICH-placebo	Removing Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Experimental: AICH-PXZY	AICH-without PXZY	Removing Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Placebo: AICH-placebo	AICH-PXZY	The placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Placebo: AICH-placebo	AICH-placebo	The placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Experimental: AICH-without PXZY	AICH-PXZY	Removing Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Experimental: AICH-without PXZY	AICH-without PXZY	Removing Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).

Primary Outcome Measures

Name	Time	Method
Hematoma enlargement	6-72h within onset, 24hrs, 10-14days	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)

Secondary Outcome Measures

Name	Time	Method
GCS scoring scale	6-72hours within onset, 24hours later, 3 months	The Glasgow score was used to assess the coma index.
National Institute of Health of stroke scale	6-72hours within onset, 24hours later, 3 months	The NIHSS is for evaluation of neurological deficits.
modified rankin scale	3 months	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.
BI index	3 months	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.
Social function activity questionnaire(FAQ)	3 months	FAQ is mainly to know the quality of life and living habits of the patients and their families.
fatality rate	3 months	Any cause of death within the entire treatment 10ds and follow-up 90ds.

Trial Locations

Locations (2)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Science and Technology Agency; 🇨🇳 Guangzhou, Guangdong, China