Clinical Re-evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Drug: ICH-1(herbal medicine with Hirudo, Tabanus)Drug: ICH-2(herbal medicine without Hirudo, Tabanus)Drug: placebo
- Registration Number
- NCT01918722
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 360
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICH-1 ICH-1(herbal medicine with Hirudo, Tabanus) herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function ICH-2 ICH-2(herbal medicine without Hirudo, Tabanus) herbal medicine without Hirudo, Tabanus,Only 6 herbals placebo herbal medicine placebo Placebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days
- Primary Outcome Measures
Name Time Method Hematoma enlargement 24hrs, 10-14days
- Secondary Outcome Measures
Name Time Method fatality rate 3 month modified rankin scale 3 months National Institute of Health of stroke scale 10-14days, 90days
Trial Locations
- Locations (15)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Panyu Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Boji-affiliated Hospital of Sun Yat-sen University
🇨🇳Zengcheng, Guangdong, China
The hospital of Chinese Medicine of Conghua City
🇨🇳Conghua, Guangdong, China
1st people's hospital of Yueyang city
🇨🇳Yueyang, Hunan, China
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Guangzhou Hospital of Integrated traditional and west medicine
🇨🇳Guangzhou, Guangdong, China
Boluo County People's Hospital
🇨🇳Huizhou, Guangdong, China
Jiangmen Wuyi Traditional Chinese Medicine Hospital
🇨🇳Jiangmen, Guangdong, China
Yangjiang Hospital of Traditional Chinese Medicine
🇨🇳Yangjiang, Guangdong, China
Zengcheng City Hospital of traditional Chinese Medicine
🇨🇳Zengcheng, Guangdong, China
Liaocheng City People's Hospital
🇨🇳Liaocheng, Shandong, China
Shouguang City People's Hospital
🇨🇳Shouguang, Shandong, China
Shenyang No.2 traditional Chinese medical hospital
🇨🇳Shenyang, Liaoning, China
Lianjiang People's hospital
🇨🇳Lianjiang, Guangdong, China