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

China Medical University

Status and phase: Unknown; Phase 4

Conditions: Intracranial Arterial Stenosis

Treatments: Drug: placebo; Drug: Chinese Herb Huang-Chi-Wu-Wu-Tang

Study type: Interventional

Funder types: Other

Identifiers

NCT01553643

DMR98-IRB-281

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 41+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Chinese Herb Huang-Chi-Wu-Wu-Tang

Experimental group

Treatment:

Drug: Chinese Herb Huang-Chi-Wu-Wu-Tang

Placebo

Placebo Comparator group

Treatment:

Drug: placebo