A Randomized Double Blind Placebo Control Study of Huang-Chi-Wu-Wu- Tang in Patients With Intracranial Arterial Stenosis
Primary Purpose
Intracranial Arterial Stenosis
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Chinese Herb Huang-Chi-Wu-Wu-Tang
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Arterial Stenosis focused on measuring Huang-Chi-Wu-Wu-Tang, Intracranial arterial prominent stenosis
Eligibility Criteria
Inclusion Criteria:
- Had received Transcranial Doppolar Sonography.
- Age >40 years old.
- Gender: Male or female.
- The subject or their legal representative gave written informed consent to participate.
Meet with one of the two Transcranial Doppolar Sonography results below:
The evaluated standard of MCA M1 stenosis of 50-99% are as follows:
- PSV >140 cm/s
- MFV >100 cm/s
The evaluated standard of BA stenosis of 50-99% are as follows:
- PSV >100 cm/s
- MFV >60 cm/s
Exclusion Criteria:
- Refused to sign the Informed Consent Form.
- Too irritable to accept the evaluation.
- Age ≦40 years old.
- Major diseases such as Myocardial Infarction、Heart failure、Chronic pulmonary obstructive disease(COPD)with dyspnea、Liver failure or Renal failure.
- Pregnancy or breast-feeding.
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Chinese Herb Huang-Chi-Wu-Wu-Tang
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Primary outcome measure was the improvement hemodynamics at intracranial vessels in the M1 segment of middle cerebral artery (MCA) or basilar artery (BA) shown in transcranial color-coded sonography (TCCS).
Secondary Outcome Measures
Full Information
NCT ID
NCT01553643
First Posted
March 7, 2012
Last Updated
March 13, 2012
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01553643
Brief Title
A Randomized Double Blind Placebo Control Study of Huang-Chi-Wu-Wu- Tang in Patients With Intracranial Arterial Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
5. Study Description
Brief Summary
Intracranial arterial prominent stenosis (IAPS) is one of main cause of stroke especially in Asia. Although antiplatelet aggregative or anticoagulant agent and even surgical operation are used to treat patients with IAPS, the incidence of stroke occurrence still remains high. In addition, symptomatic IAPS most common cause continuous deterioration, thus, increase the incidence of stroke. Therefore, there is a good method to reduce the inceidence of stroke that is to prevent the progressive deterioration of IAPS.
Huang-Chi-Wu-Wu-Tang is made of Astrgalus membranaceus (Fisch.) Gge , Paeonia lactiflora Pall , Cinnamom Twig , Zingiber officinale Rose , Ziziphus jujube Mill , and can treat hemiplegia in the traditional Chinese medicine writings. Astragaloside IV is a component of Astrgalus membranaceus, may reduce th cerebral infarction area in middle cerebral arterial occlusion mice. The investigators previous studies have known that paeoniflorin that a component of Paeonia lactiflora Pall can decrease the cerebral infarction area and neurological deficit in middle cerebral arterial occlusion rats. Therefore, the purpose of the present study was to investigate the effect of Huang-Chi-Wu-Wu-Tang on patients with IAPS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arterial Stenosis
Keywords
Huang-Chi-Wu-Wu-Tang, Intracranial arterial prominent stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chinese Herb Huang-Chi-Wu-Wu-Tang
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chinese Herb Huang-Chi-Wu-Wu-Tang
Intervention Description
Huang-Chi-Wu-Wu-Tang at a rate of 3g two times per day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
at a rate of 3g two times per day
Primary Outcome Measure Information:
Title
Primary outcome measure was the improvement hemodynamics at intracranial vessels in the M1 segment of middle cerebral artery (MCA) or basilar artery (BA) shown in transcranial color-coded sonography (TCCS).
Time Frame
3 years(all patients)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Had received Transcranial Doppolar Sonography.
Age >40 years old.
Gender: Male or female.
The subject or their legal representative gave written informed consent to participate.
Meet with one of the two Transcranial Doppolar Sonography results below:
The evaluated standard of MCA M1 stenosis of 50-99% are as follows:
PSV >140 cm/s
MFV >100 cm/s
The evaluated standard of BA stenosis of 50-99% are as follows:
PSV >100 cm/s
MFV >60 cm/s
Exclusion Criteria:
Refused to sign the Informed Consent Form.
Too irritable to accept the evaluation.
Age ≦40 years old.
Major diseases such as Myocardial Infarction、Heart failure、Chronic pulmonary obstructive disease(COPD)with dyspnea、Liver failure or Renal failure.
Pregnancy or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Hsiang Liu, MD.
Phone
886-4-22052121
Ext
7635
Email
greengen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung Hsiang Liu, MD.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taiching
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung Hsiang Liu, MD.
12. IPD Sharing Statement
Learn more about this trial
A Randomized Double Blind Placebo Control Study of Huang-Chi-Wu-Wu- Tang in Patients With Intracranial Arterial Stenosis
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