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

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ClinicalTrials.gov Identifier: NCT01553643
Recruitment Status : Unknown
Verified March 2012 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2012
Last Update Posted : March 14, 2012
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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.


Condition or disease Intervention/treatment Phase
Intracranial Arterial Stenosis Drug: Chinese Herb Huang-Chi-Wu-Wu-Tang Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2010
Estimated Primary Completion Date : November 2012

Arm Intervention/treatment
Experimental: Chinese Herb Huang-Chi-Wu-Wu-Tang Drug: Chinese Herb Huang-Chi-Wu-Wu-Tang
Huang-Chi-Wu-Wu-Tang at a rate of 3g two times per day

Placebo Comparator: Placebo Drug: placebo
at a rate of 3g two times per day




Primary Outcome Measures :
  1. 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) ]


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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Had received Transcranial Doppolar Sonography.
  2. Age >40 years old.
  3. Gender: Male or female.
  4. The subject or their legal representative gave written informed consent to participate.
  5. 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:

  1. Refused to sign the Informed Consent Form.
  2. Too irritable to accept the evaluation.
  3. Age ≦40 years old.
  4. Major diseases such as Myocardial Infarction、Heart failure、Chronic pulmonary obstructive disease(COPD)with dyspnea、Liver failure or Renal failure.
  5. Pregnancy or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553643


Contacts
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Contact: Chung Hsiang Liu, MD. 886-4-22052121 ext 7635 greengen@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taiching, Taiwan
Contact: Chung Hsiang Liu, MD.         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Chung Hsiang Liu, MD. China Medical University Hospital

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01553643     History of Changes
Other Study ID Numbers: DMR98-IRB-281
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012

Keywords provided by China Medical University Hospital:
Huang-Chi-Wu-Wu-Tang
Intracranial arterial prominent stenosis

Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical