Clinical trial NCT01918722: Clinical Re-evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
Official title: Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intracerebral Hemorrhage
Keywords: Activating blood stagnation and expelling blood stasis
Hematoma enlargement
herbal medicine
traditional chinese medicine
random clinical trial
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Hematoma enlargement
timeFrame: 24hrs, 10-14days
Secondary outcomes:
measure: fatality rate
timeFrame: 3 month
measure: modified rankin scale
timeFrame: 3 months
measure: National Institute of Health of stroke scale
timeFrame: 10-14days, 90days
Other outcomes:
Locations:
city: Conghua
country: China
facility: The hospital of Chinese Medicine of Conghua City
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Hospital of Integrated traditional and west medicine
state: Guangdong
city: Guangzhou
country: China
facility: Panyu Hospital of Chinese Medicine
state: Guangdong
city: Huizhou
country: China
facility: Boluo County People's Hospital
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Wuyi Traditional Chinese Medicine Hospital
state: Guangdong
city: Lianjiang
country: China
facility: Lianjiang People's hospital
state: Guangdong
city: Yangjiang
country: China
facility: Yangjiang Hospital of Traditional Chinese Medicine
state: Guangdong
city: Zengcheng
country: China
facility: Zengcheng City Hospital of traditional Chinese Medicine
state: Guangdong
city: Zengcheng
country: China
facility: Boji-affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Yueyang
country: China
facility: 1st people's hospital of Yueyang city
state: Hunan
city: Shenyang
country: China
facility: Shenyang No.2 traditional Chinese medical hospital
state: Liaoning
city: Liaocheng
country: China
facility: Liaocheng City People's Hospital
state: Shandong
city: Shouguang
country: China
facility: Shouguang City People's Hospital
state: Shandong
Study officials:
affiliation: Guangdong Province Hospital of Tradtional Chinese Medicine
name: Jianwen m Guo, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeng L, Tang G, Wang J, Zhong J, Xia Z, Li J, Chen G, Zhang Y, Luo S, Huang G, Zhao Q, Wan Y, Chen C, Zhu K, Qiao H, Wang J, Huang T, Liu X, Zhang Q, Lin R, Li H, Gong B, Chen X, Zhou Y, Wen Z, Guo J. Safety and efficacy of herbal medicine for acute intracerebral hemorrhage (CRRICH): a multicentre randomised controlled trial. BMJ Open. 2019 May 9;9(5):e024932. doi: 10.1136/bmjopen-2018-024932.
citation: Zeng L, Guo J, Wang J, Zhang Q, Li H, Lin R. Clinical re-evaluation of removing blood stasis therapy in treating acute intracerebral hemorrhage safety and efficacy: a protocol for a randomized, controlled, multicenter study (CRRICH Trial). Springerplus. 2016 Sep 1;5(1):1466. doi: 10.1186/s40064-016-3136-y. eCollection 2016.