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

NCT ID: NCT01553643

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

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.

Conditions

Intracranial Arterial Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Chinese Herb Huang-Chi-Wu-Wu-Tang

Group Type: EXPERIMENTAL

Chinese Herb Huang-Chi-Wu-Wu-Tang

Intervention Type: DRUG

Huang-Chi-Wu-Wu-Tang at a rate of 3g two times per day

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

at a rate of 3g two times per day

Interventions

Chinese Herb Huang-Chi-Wu-Wu-Tang

Huang-Chi-Wu-Wu-Tang at a rate of 3g two times per day

Intervention Type: DRUG

placebo

at a rate of 3g two times per day

Intervention Type: DRUG

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.

• Minimum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chung Hsiang Liu, MD.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taiching, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chung Hsiang Liu, MD.

Role: CONTACT

greengen@gmail.com

886-4-22052121 ext. 7635

Facility Contacts

Chung Hsiang Liu, MD.

Role: primary

Other Identifiers

DMR98-IRB-281

Identifier Type: -

Identifier Source: org_study_id