Clinical trial NCT01553643: A Randomized Double Blind Placebo Control Study of Huang-Chi-Wu-Wu- Tang in Patients With Intracranial Arterial Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intracranial Arterial Stenosis
Keywords: Huang-Chi-Wu-Wu-Tang
Intracranial arterial prominent stenosis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: 3 years(all patients)
Secondary outcomes:
Other outcomes:
Locations:
city: Taiching
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Chung Hsiang Liu, MD.
role: PRINCIPAL_INVESTIGATOR
References: