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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354026
Recruitment Status : Not yet recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Collaborators:
Lianjiang people's Hospital
Shenyang Second Hospital of traditional Chinese Medicine
The third people's Hospital of Hubei Province
Liaocheng People's Hospital
Zengcheng Hospital of traditional Chinese Medicine
Shouguang people's Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage, Hypertensive Traditional Chinese Medicine Drug: AICH-PXZY Drug: AICH-without PXZY Drug: AICH-placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Our randomized program was completed by the key research laboratory of clinical research from the Traditional Chinese medicine Hospital of Guangdong Province. We design 306 cases into three groups: Group A, B, C in the proportion of 1:1:1. Group A is the experimental group used RBS, which include 8 herbals. Group B is the experimental group used PBS, which include all the herbals in Group A except Leech and Tabanus, rhubarb. Group C is a placebo group. This study adopts a stratified random sampling method and intra slice randomization on the basis of using PROC PLAN progress on SAS V9.2. On the other hand, this trial measures and the control measures will be made blind doubly. The surface of the opaque random envelopes will indicate the information of the test name, hospital name and the entry sequence number of patient. The research process of incorporating patient, dispensing medicine depending on the random envelopes and ect will all be supervised by the researchers each other.
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: 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 Name: herbal medicine without Hirudo, Tabanus

Drug: AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Other Name: 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 Name: 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 Name: herbal medicine without Hirudo, Tabanus

Drug: AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Other Name: 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 Name: 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 Name: herbal medicine without Hirudo, Tabanus

Drug: AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Other Name: Placebo




Primary Outcome Measures :
  1. Hematoma enlargement [ Time Frame: 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 :
  1. GCS scoring scale [ Time Frame: 6-72hours within onset, 24hours later, 3 months ]
    The Glasgow score was used to assess the coma index.

  2. National Institute of Health of stroke scale [ Time Frame: 6-72hours within onset, 24hours later, 3 months ]
    The NIHSS is for evaluation of neurological deficits.

  3. BI index [ Time Frame: 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.

  4. Social function activity questionnaire(FAQ) [ Time Frame: 3 months ]
    FAQ is mainly to know the quality of life and living habits of the patients and their families.

  5. fatality rate [ Time Frame: 3 months ]
    Any cause of death within the entire treatment 10ds and follow-up 90ds.

  6. modified rankin scale [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354026


Contacts
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Contact: Jianwen J Guo, Doctor +86 13724899379 jianwen_guo@qq.com
Contact: Qixin Q Zhang, Master +86 15626450556 446763061@qq.com

Locations
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China, Guangdong
Guangdong Provincial Science and Technology Agency
Guangzhou, Guangdong, China, 510033
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Lianjiang people's Hospital
Shenyang Second Hospital of traditional Chinese Medicine
The third people's Hospital of Hubei Province
Liaocheng People's Hospital
Zengcheng Hospital of traditional Chinese Medicine
Shouguang people's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03354026    
Other Study ID Numbers: JDZX2015048
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangzhou University of Traditional Chinese Medicine:
Blood-breaking Decotion
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Intracranial Hemorrhage, Hypertensive
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases