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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01918722
First received: April 18, 2013
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Intracerebral Hemorrhage
Drug: ICH-1(herbal medicine with Hirudo, Tabanus)
Drug: placebo
Drug: ICH-2(herbal medicine without Hirudo, Tabanus)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety

Resource links provided by NLM:


Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Hematoma enlargement [ Time Frame: 24hrs, 10-14days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • fatality rate [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • modified rankin scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • National Institute of Health of stroke scale [ Time Frame: 10-14days, 90days ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: pxzyp

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918722

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

No publications provided

Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01918722     History of Changes
Other Study ID Numbers: JDZX2012074  JDZX2012074 
Study First Received: April 18, 2013
Last Updated: November 9, 2015
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
Activating blood stagnation and expelling blood stasis
Hematoma enlargement
herbal medicine
traditional chinese medicine
random clinical trial

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on February 04, 2016