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

NCT01553643 | Unknown Phase 4

• 1 other identifier: DMR98-IRB-281
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Huang-Chi-Wu-Wu-Tang; Intracranial arterial prominent stenosis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Chinese Herb Huang-Chi-Wu-Wu-Tang

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Chinese Herb Huang-Chi-Wu-Wu-Tang DRUG

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

Chinese Herb Huang-Chi-Wu-Wu-Tang

placebo DRUG

at a rate of 3g two times per day

Placebo

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had received Transcranial Doppolar Sonography.
• Age \>40 years old.
• Gender: Male or female.
• The subject or their legal representative gave written informed consent to participate.
• 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

You may not qualify if:

• Refused to sign the Informed Consent Form.
• Too irritable to accept the evaluation.
• Age ≦40 years old.
• Major diseases such as Myocardial Infarction、Heart failure、Chronic pulmonary obstructive disease(COPD）with dyspnea、Liver failure or Renal failure.
• Pregnancy or breast-feeding.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taiching, Taiwan

RECRUITING

Study Officials

• Chung Hsiang Liu, MD.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Hsiang Liu, MD.

CONTACT

886-4-22052121; greengen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 14, 2012
• Study Start: January 1, 2010
• Primary Completion: November 1, 2012
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

TW (1)