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

Phase 4

• Conditions: Intracranial Arterial Stenosis
• Interventions: Drug: Chinese Herb Huang-Chi-Wu-Wu-Tang; Drug: placebo

• Registration Number: NCT01553643
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-13
• Last Update Submitted: 2012-03-13
• Study First Posted: 2012-03-14
• Last Update Posted: 2012-03-14
• Primary Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese Herb Huang-Chi-Wu-Wu-Tang	Chinese Herb Huang-Chi-Wu-Wu-Tang	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taiching, Taiwan