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

NCT01553643 — Phase 4, Unknown, 80 participants, China Medical University Hospital

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Registry	NCT01553643
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	80 (Estimated)
Sponsor	China Medical University Hospital (Other)
Conditions	Intracranial Arterial Stenosis
Interventions	Chinese Herb Huang-Chi-Wu-Wu-Tang, placebo (Drug)
Dates	start 2010-01-01, primary completion 2012-11-01 (estimated), first posted 2012-03-14, last updated 2012-03-14
Locations	1 site in Taiwan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Chinese Herb Huang-Chi-Wu-Wu-Tang	Experimental	Drug: Chinese Herb Huang-Chi-Wu-Wu-Tang
Placebo	Placebo comparator	Drug: placebo

Chinese Herb Huang-Chi-Wu-Wu-Tang (Drug): Huang-Chi-Wu-Wu-Tang at a rate of 3g two times per day
placebo (Drug): at a rate of 3g two times per day

+Outcome measures

Primary outcomes

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)]

+Eligibility

Sex: All, ages: 41 Years to any

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.

+Locations (1)

Facility	City	Country	Status
China Medical University Hospital	Taiching	Taiwan	Recruiting

+Investigators

Chung Hsiang Liu, MD., Principal investigator, China Medical University Hospital