Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine
Primary Purpose
Aneurysm
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
herbal drug
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysm focused on measuring delayed vasospasm,, medicine,, standardization
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 14-80 years old patients;
- Comply with the diagnostic criteria for Chinese and Western medicine;
- Comply with embolization of intracranial aneurysms or cranial aneurysm surgery indications;
- Preoperative Hunt and Hess grade of Ⅰ ~ Ⅳ; The first disease or previous history of stroke but no sequelae;
- Acceptance within 72h onset cranial aneurysm embolization or craniotomy aneurysm surgeon;
- Informed consent;
Exclusion Criteria:
- The age of 14 years of age or in patients over 80 years of age;
- By hypertension, a variety of blood diseases, amyloid angiopathy, cerebral arteritis, cerebral abnormal vascular network (moyamoya disease), brain tumor brain metastases as a result of bleeding;
- Associated with cardiovascular, liver and kidney and hematopoietic system of primary disease, mental illness;
- 72h of onset did not receive cranial aneurysm embolization or craniotomy for aneurysm surgery were;
Sites / Locations
- Guangdong Provincial Science and Technology AgencyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
herbal drug
Placebo
Arm Description
Traditional Chinese herbal drug
Outcomes
Primary Outcome Measures
The incidence of DCVS after aneurysmal postoperative
after 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine
Secondary Outcome Measures
1 month, 3 month mortality
after 3-months chinese medicine treatment, through evaluating 1 month, 3 month mortality after cerebral aneurysms , to assess the efficacy of Chinese medicine
Full Information
NCT ID
NCT01840761
First Posted
December 12, 2011
Last Updated
April 25, 2013
Sponsor
Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01840761
Brief Title
Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine
Official Title
Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Delayed vasospasm (DCVS) is the most serious complication of aneurysmal subarachnoid hemorrhage (aSAH) perioperative period ,the incidence rate up to 30% to 90%, and often can cause severe brain ischemia or brain damage of delayed ischemic and even lead to cerebral infarction, to be the main factor of deadly and severe disability . (aSAH) perioperative delayed vasospasm (CVS) is the bottleneck to restrict the long-term effect. Since there is no standard clinical treatment programs, limiting the advantages and characteristics of traditional Chinese medicine to play.Guangdong Provincial Hospital of TCM is the province's Medical Center encephalopathy, treated 100 brain aneurysm patients each year, more than 80 times craniotomies and surgical interventions , with a rich source of patiengs to carry out the study. In this study, on the basis studies on hemorrhagic stroke of a yin and yang syndrome and comprehensive treatment programe of the State 1995,the 15th research , in accordance with characteristics of the pathophysiology and understanding of cause and pathogenesis in aSAH perioperative period , through expert advice and review of the literature, under the guidance of Liu Maocai who isChinese medicine practitioners of Guangdong province , from diagnosis, diagnosis and treatment,prescription drugs, and other aspects of efficacy evaluation, developmenting a standardized treatment program of delayed CVS after aSAH . To evaluate the efficacy of the standardized program by prospective, randomized,controlled clinical trial,improving the postoperative results, reducting significantly the mortality and morbidity patients with cerebral aneurysms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm
Keywords
delayed vasospasm,, medicine,, standardization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
herbal drug
Arm Type
Experimental
Arm Description
Traditional Chinese herbal drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
herbal drug
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The incidence of DCVS after aneurysmal postoperative
Description
after 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine
Time Frame
3 months
Secondary Outcome Measure Information:
Title
1 month, 3 month mortality
Description
after 3-months chinese medicine treatment, through evaluating 1 month, 3 month mortality after cerebral aneurysms , to assess the efficacy of Chinese medicine
Time Frame
14days,1 month,3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between the ages of 14-80 years old patients;
Comply with the diagnostic criteria for Chinese and Western medicine;
Comply with embolization of intracranial aneurysms or cranial aneurysm surgery indications;
Preoperative Hunt and Hess grade of Ⅰ ~ Ⅳ; The first disease or previous history of stroke but no sequelae;
Acceptance within 72h onset cranial aneurysm embolization or craniotomy aneurysm surgeon;
Informed consent;
Exclusion Criteria:
The age of 14 years of age or in patients over 80 years of age;
By hypertension, a variety of blood diseases, amyloid angiopathy, cerebral arteritis, cerebral abnormal vascular network (moyamoya disease), brain tumor brain metastases as a result of bleeding;
Associated with cardiovascular, liver and kidney and hematopoietic system of primary disease, mental illness;
72h of onset did not receive cranial aneurysm embolization or craniotomy for aneurysm surgery were;
Facility Information:
Facility Name
Guangdong Provincial Science and Technology Agency
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianwen Guo, dr.
Phone
020-81887233
Ext
34530
Email
jianwen_guo@msn.com
First Name & Middle Initial & Last Name & Degree
Jianwen Guo, Dr.
12. IPD Sharing Statement
Links:
URL
http://www.gdhtcm.com
Description
Related Info
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Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine
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