Clinical Re-evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

March 10, 2016 updated by: Guangzhou University of Traditional Chinese Medicine

Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety

In order to investigate the time window of acute intracerebral hemorrhage(AICH) by "Blood Activating and Stasis Dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the therapy lasts two weeks, and the follow up should last three months. The main indexes are mortality rate, disability rate and the brain hematoma situation. The review is made by the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

objective: to investigate the safety and effect of acute cerebral hemorrhage treated with "Blood Activating and Stasis Dispersing" therapy and to verify the traditional methods can influence the brain hematoma enlargement or not.

Methods: from 2013.8 to 2015.12, 360 cases of AICH will be included in 13 research centers. Patients are randomly into 3 groups within 6hrs from onset,such as, group A, blood activating herbal medicine (8 herbals), Group B, herbal medicine without blood activating herbal(6 herbals), Group C, placebo for 10days. All the patients will be treated according AHA guideline of AICH. All patients will be set to the CT at the onset, 24h later and 10-14days after treatment. So the rate of enlargement of brain hematoma 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)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Conghua, Guangdong, China, 5109000
        • The hospital of Chinese Medicine of Conghua City
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine
      • Guangzhou, Guangdong, China, 510800
        • Guangzhou Hospital of Integrated traditional and west medicine
      • Guangzhou, Guangdong, China, 511400
        • Panyu Hospital of Chinese Medicine
      • Huizhou, Guangdong, China, 514610
        • Boluo County People's Hospital
      • Jiangmen, Guangdong, China, 529000
        • Jiangmen Wuyi Traditional Chinese Medicine Hospital
      • Lianjiang, Guangdong, China, 524400
        • Lianjiang People's Hospital
      • Yangjiang, Guangdong, China, 529500
        • Yangjiang Hospital of Traditional Chinese Medicine
      • Zengcheng, Guangdong, China, 510000
        • Zengcheng City Hospital of traditional Chinese Medicine
      • Zengcheng, Guangdong, China, 511300
        • Boji-affiliated Hospital of Sun Yat-sen University
    • Hunan
      • Yueyang, Hunan, China, 414000
        • 1st people's hospital of Yueyang city
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Shenyang No.2 traditional Chinese medical hospital
    • Shandong
      • Liaocheng, Shandong, China, 252000
        • Liaocheng city people's hospital
      • Shouguang, Shandong, China, 262700
        • Shouguang City People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no younger than 18 yrs
  • acute cerebral hemorrhage confirmed by brain CT scan
  • within 6 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ICH-1
herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function
Drug: ICH-1(herbal medicine with Hirudo, Tabanus)
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
Other Names:
  • PXZY
ACTIVE_COMPARATOR: ICH-2
herbal medicine without Hirudo, Tabanus,Only 6 herbals
Drug: ICH-2(herbal medicine without Hirudo, Tabanus)
(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
Other Names:
  • NPXZY
PLACEBO_COMPARATOR: placebo herbal medicine
Placebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days
Drug: placebo
placebo herbal medicine, one dose,bid, for 10 days
Other Names:
  • pxzyp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hematoma enlargement
Time Frame: 24hrs, 10-14days
24hrs, 10-14days

Secondary Outcome Measures

Outcome Measure
Time Frame
fatality rate
Time Frame: 3 month
3 month
modified rankin scale
Time Frame: 3 months
3 months
National Institute of Health of stroke scale
Time Frame: 10-14days, 90days
10-14days, 90days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JDZX2012074 (OTHER_GRANT: China national clinical study base project of TCM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study has recruited 278 subjects by so far

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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