Clinical Re-evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
1 other identifier
interventional
360
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2013
Typical duration for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
August 8, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 11, 2016
March 1, 2016
2.7 years
April 18, 2013
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hematoma enlargement
24hrs, 10-14days
Secondary Outcomes (3)
fatality rate
3 month
modified rankin scale
3 months
National Institute of Health of stroke scale
10-14days, 90days
Study Arms (3)
ICH-1
EXPERIMENTALherbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function
ICH-2
ACTIVE COMPARATORherbal medicine without Hirudo, Tabanus,Only 6 herbals
placebo herbal medicine
PLACEBO COMPARATORPlacebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days
Interventions
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
placebo herbal medicine, one dose,bid, for 10 days
(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
Guangzhou Hospital of Integrated traditional and west medicine
Guangzhou, Guangdong, 510800, China
Panyu Hospital of Chinese Medicine
Guangzhou, Guangdong, 511400, China
Boluo County People's Hospital
Huizhou, Guangdong, 514610, China
Jiangmen Wuyi Traditional Chinese Medicine Hospital
Jiangmen, Guangdong, 529000, China
The hospital of Chinese Medicine of Conghua City
Jiekou, Guangdong, 5109000, China
Lianjiang People's hospital
Lianjiang, Guangdong, 524400, China
Zengcheng City Hospital of traditional Chinese Medicine
Licheng, Guangdong, 510000, China
Boji-affiliated Hospital of Sun Yat-sen University
Licheng, Guangdong, 511300, China
Yangjiang Hospital of Traditional Chinese Medicine
Yangjiang, Guangdong, 529500, China
1st people's hospital of Yueyang city
Yueyang, Hunan, 414000, China
Shenyang No.2 traditional Chinese medical hospital
Shenyang, Liaoning, 110000, China
Liaocheng City People's Hospital
Liaocheng, Shandong, 252000, China
Shouguang City People's Hospital
Shouguang, Shandong, 262700, China
Related Publications (2)
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.
PMID: 31076468DERIVEDZeng 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.
PMID: 27652041DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianwen m Guo, doctor
Guangdong Province Hospital of Tradtional Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2013
First Posted
August 8, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
March 11, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share
The study has recruited 278 subjects by so far