Trial record 2 of 111 for:    herbal medicine | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Guangzhou University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01918722
First received: April 18, 2013
Last updated: February 28, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Intracerebral Hemorrhage
Drug: ICH-1(herbal medicine with Hirudo, Tabanus)
Drug: placebo
Drug: ICH-2(herbal medicine without Hirudo, Tabanus)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety

Resource links provided by NLM:


Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Hematoma enlargement [ Time Frame: 24hrs, 10-14days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • fatality rate [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • modified rankin scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • National Institute of Health of stroke scale [ Time Frame: 10-14days, 90days ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICH-1
herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function
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
Other Name: PXZY
Active Comparator: ICH-2
herbal medicine without Hirudo, Tabanus,Only 6 herbals
Drug: ICH-2(herbal medicine without Hirudo, Tabanus)
(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
Other Name: NPXZY
Placebo Comparator: placebo herbal medicine
Placebo :granula,dose twice a day by Oral or nasogastric tube for 10 days
Drug: placebo
placebo herbal medicine, one dose,bid, for 10 days
Other Name: pxzyp

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918722

Contacts
Contact: Jianwen Guo, doctor 0086-13724899379 jianwen_guo@msn.com
Contact: Yefeng Cai, master (08620)81887233 ext 34530 caiyefeng@126.com

Locations
China, Guangdong
The hospital of Chinese Medicine of Conghua City Recruiting
Conghua, Guangdong, China, 5109000
Contact: Jiexia li    13926183618    lijie_xia@126.com   
Principal Investigator: Jiexia Li         
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: songhua xiao, director    86-20-13802782299    docliujun@hotmail.com   
Contact: fengying Zhu, investigator    86-2013719339937    stroketcm1518@126.com   
Principal Investigator: songhua Xiao, MD         
Guangdong Provincial Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jianwen Guo, MD    (08620)81887233 ext 34530    jianwen_guo@msn.com   
Contact: Lixin Wang, MD    (08620)81887233 ext 34530    plawlx@126.com   
Principal Investigator: JIANWEN GUO, MD         
Guangzhou Hospital of Integrated traditional and west medicine Recruiting
Guangzhou, Guangdong, China, 510800
Contact: Chaojun Chen    13926297698 ext 020    ccjbs@126.com   
Contact: Jianfang Hu    15814867166 ext 020    hjf5630@163.com   
Principal Investigator: Chaojun Chen         
Sub-Investigator: Jianfang Hu         
Panyu Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 511400
Contact: Kaiyun Zhu    13719364328 ext 020      
Contact: Ningping Liu    13660090303 ext 020    lnp123@qq.com   
Principal Investigator: Kaiyun Zhu         
Boluo County People's Hospital Recruiting
Huizhou, Guangdong, China, 514610
Contact: Guangsheng Chen    18928355925 ext 0752    18928355925@189.cn   
Contact: Chang Lin    15018613961 ext 0752    37990154@qq.com   
Principal Investigator: Guangsheng Chen         
Sub-Investigator: Chang Lin         
Jiangmen Wuyi Traditional Chinese Medicine Hospital Recruiting
Jiangmen, Guangdong, China, 529000
Contact: qianshan zhao, MD    13686981584    qsmj2004@163.com   
Principal Investigator: qianshan zhao, MD         
Lianjiang People's hospital Recruiting
Lianjiang, Guangdong, China, 524400
Contact: Hua Wang    13729134569 ext 0759    zjwanghua2007@163.com   
Principal Investigator: Hua Wang         
Yangjiang Hospital of Traditional Chinese Medicine Not yet recruiting
Yangjiang, Guangdong, China, 529500
Contact: Gan Huang    13829816352 ext 0662    sunqiaojie@163.com   
Principal Investigator: Gan Huang         
Zengcheng City Hospital of traditional Chinese Medicine Recruiting
Zengcheng, Guangdong, China, 510000
Contact: Qilan Wang    13556057528 ext 020    gdzcwql@126.com   
Contact: Huiying Zhu    13430365694 ext 020    Zhuhuiying1980@126.com   
Principal Investigator: Qilan Wang         
Sub-Investigator: Huiying Zhu         
Boji-affiliated Hospital of Sun Yat-sen University Recruiting
Zengcheng, Guangdong, China, 511300
Contact: Jianbing Zhong, MD    13711547120 ext 020    zjbrmyy@126.com   
Principal Investigator: Jianbing Zhong         
China, Hunan
1st people's hospital of Yueyang city Recruiting
Yueyang, Hunan, China, 414000
Contact: luoqing Li, MD    13873094682    luoql99s@163.com   
Principal Investigator: Luoqing Li, MD         
China, Liaoning
Shenyang No.2 traditional Chinese medical hospital Recruiting
Shenyang, Liaoning, China, 110000
Contact: Zhengkun Wang    13604182559 ext 024    Wzk753@hotmail.com   
Principal Investigator: Zhengkun Wang         
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
Principal Investigator: Jianwen m Guo, doctor Guangdong Province Hospital of Tradtional Chinese Medicine
  More Information

No publications provided

Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01918722     History of Changes
Other Study ID Numbers: JDZX2012074, JDZX2012074
Study First Received: April 18, 2013
Last Updated: February 28, 2014
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
Activating blood stagnation and expelling blood stasis
Hematoma enlargement
herbal medicine
traditional chinese medicine
random clinical trial

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014