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

Intracranial Arterial Stenosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01553643
• Other study ID #: DMR98-IRB-281
• Status: Recruiting
• Phase: Phase 4
• First received: March 7, 2012
• Last updated: March 13, 2012
• Start date: January 2010

Study information

• Verified date: March 2012
• Source: China Medical University Hospital
• Contact: Chung Hsiang Liu, MD.
• Phone: 886-4-22052121
• Email: greengen[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intracranial Arterial Stenosis

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taiching

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes