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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Guangzhou University of Traditional Chinese Medicine

Current Primary Outcome: Hematoma enlargement [ Time Frame: 24hrs, 10-14days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Guangzhou University of Traditional Chinese Medicine

Dates:
Date Received: April 18, 2013
Date Started: October 2013
Date Completion: December 2016
Last Updated: March 10, 2016
Last Verified: March 2016