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

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.

Study Overview

• Status: Unknown
• Conditions: Traditional Chinese Medicine; Intracerebral Hemorrhage, Hypertensive
• Intervention / Treatment: Drug: AICH-PXZY; Drug: AICH-without PXZY; Drug: AICH-placebo

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 Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510033
      • Guangdong Provincial Science and Technology Agency
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 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).	Drug: AICH-PXZY; 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days; Other Names: herbal medicine with Hirudo, Tabanus; Drug: AICH-without PXZY; AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days; Other Names: herbal medicine without Hirudo, Tabanus; Drug: AICH-placebo; The placebo is made up of Starch, bitter taste and cyclodextrin; Other Names: Placebo
Experimental: Experimental: 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).	Drug: AICH-PXZY; 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days; Other Names: herbal medicine with Hirudo, Tabanus; Drug: AICH-without PXZY; AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days; Other Names: herbal medicine without Hirudo, Tabanus; Drug: AICH-placebo; The placebo is made up of Starch, bitter taste and cyclodextrin; Other Names: Placebo
Placebo Comparator: 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).	Drug: AICH-PXZY; 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days; Other Names: herbal medicine with Hirudo, Tabanus; Drug: AICH-without PXZY; AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days; Other Names: herbal medicine without Hirudo, Tabanus; Drug: AICH-placebo; The placebo is made up of Starch, bitter taste and cyclodextrin; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
GCS scoring scale	The Glasgow score was used to assess the coma index.	6-72hours within onset, 24hours later, 3 months
National Institute of Health of stroke scale	The NIHSS is for evaluation of neurological deficits.	6-72hours within onset, 24hours later, 3 months
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
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
fatality rate	Any cause of death within the entire treatment 10ds and follow-up 90ds.	3 months
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

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: Liaocheng People's Hospital; Lianjiang people's Hospital; Shenyang Second Hospital of traditional Chinese Medicine; The Third People's Hospital of Hubei Province; Zengcheng Hospital of traditional Chinese Medicine; Shouguang people's Hospital

Publications and helpful links

General Publications

• Zhang Q, Zeng L, Chen X, Zhou Y, Gong B, Li H, Guo J. Clinical Evaluation of Herbal Medicine (ICH-012) in Treating Acute Cerebral Haemorrhage: Safety and Efficacy from 6- to 72-Hour Time Window (CRRICHTrial-II). Evid Based Complement Alternat Med. 2018 Aug 26;2018:3120179. doi: 10.1155/2018/3120179. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Blood-breaking Decotion
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage, Hypertensive
• Other Study ID Numbers: JDZX2015048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We will keep the IPD in secret and share that only when the agreement are shown by the Ethics committee and the project committee，including the examination results, genotype, etc.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No