A Phase 4 interventional study of ICH-1(herbal medicine with Hirudo, Tabanus) and placebo in Intracerebral Hemorrhage, sponsored by Guangzhou University of Traditional Chinese Medicine. Status unknown at 15 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-11.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Phase 4, Interventional, and Treatment
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.
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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's planned enrollment of 360 is above the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function
Drug: ICH-1(herbal medicine with Hirudo, Tabanus)
herbal medicine without Hirudo, Tabanus,Only 6 herbals
Drug: ICH-2(herbal medicine without Hirudo, Tabanus)
Placebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days
Drug: placebo
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
Also known as: PXZY
placebo herbal medicine, one dose,bid, for 10 days
Also known as: pxzyp
(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
Also known as: NPXZY
Hematoma enlargement
Time frame: 24hrs, 10-14days
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
Plan to share: Yes — The study has recruited 278 subjects by so far
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Guangzhou University of Traditional Chinese Medicine