NCT01918722

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Guangzhou University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
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
DRUG	placebo	placebo herbal medicine, one dose,bid, for 10 days
DRUG	ICH-2(herbal medicine without Hirudo, Tabanus)	(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2013-08-08
• Last updated: 2016-03-11

Locations

15 sites across 1 country: China