A Randomized Double Blind Placebo Control Study of Huang-... | NCT01553643

Studies
A Randomized Double Blind Placebo Control Study of Huang-Chi-Wu-Wu- Tang in Patients With Intracranial Arterial Stenosis

NCT01553643

Sponsor

China Medical University Hospital

Status

Unknown status

Last Update Posted

Mar 14, 2012Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

Intracranial Arterial Stenosis

Interventions

Chinese Herb Huang-Chi-Wu-Wu-Tang
placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Nov 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 7, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2012

Last Update Posted Date

Mar 14, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chinese Herb Huang-Chi-Wu-Wu-Tang	Experimental		Drug: Chinese Herb Huang-Chi-Wu-Wu-Tang
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chinese Herb Huang-Chi-Wu-Wu-Tang	Drug	Huang-Chi-Wu-Wu-Tang at a rate of 3g two times per day	Chinese Herb Huang-Chi-Wu-Wu-Tang

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).		3 years(all patients)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

41 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chung Hsiang Liu, MD.	Contact	886-4-22052121	7635	greengen@gmail.com

Overall Officials

Name	Affiliation	Role
Chung Hsiang Liu, MD.	China Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital	Recruiting	Taiching			Taiwan