Abstract | BACKGROUND: METHODS: This phase 2 clinical trial of SaiLuoTong among patients with mild-to-moderate VaD is a 26-week, multicenter, randomized, double-blind, placebo-controlled study with a subsequent 26-week, open-label extension. After a 4-week placebo run-in period, participants are centrally randomized (1:1:1) to 3 groups: group A receives SaiLuoTong 360 mg per day for 52 weeks; group B receives SaiLuoTong 240 mg per day for 52 weeks; group C (the control group) are further randomly assigned to 2 groups in a 1:1 ratio and receives placebo during the double-blind phase, then SaiLuoTong 360 mg per day or SaiLuoTong 240 mg per day during the extension phase. The primary outcome measures include the VaD assessment scale cognitive subscale and the Alzheimer Disease Cooperative Study-clinical global impression of change. Safety measures include body weight, vital signs, electrocardiography, laboratory tests, and records of adverse events. Assuming an attrition rate of 20%, at least 372 patients are required to obtain a statistical power of 80%. RESULTS: The first patient was enrolled into the study in April 2012 and the completion of the study is expected in September 2014. CONCLUSIONS: The rigorous methodology of the study will hopefully move forward the scientific evaluation of traditional Chinese medicine in treatment of VaD. The results of the present study will provide high-quality evidence on the effect of SaiLuoTong in patients with VaD and has the potential to establish a novel therapeutic approach for this disorder.
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Authors | Junhua Liang, Fang Li, Cuibai Wei, Haiqing Song, Liyong Wu, Yi Tang, Jianping Jia |
Journal | Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
(J Stroke Cerebrovasc Dis)
2014 Nov-Dec
Vol. 23
Issue 10
Pg. 2626-2634
ISSN: 1532-8511 [Electronic] United States |
PMID | 25294055
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Drugs, Chinese Herbal
- sailuotong
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Topics |
- Aged
- Cognition
(drug effects)
- Dementia, Vascular
(drug therapy)
- Double-Blind Method
- Drugs, Chinese Herbal
(administration & dosage, therapeutic use)
- Female
- Humans
- Male
- Medicine, Chinese Traditional
(adverse effects, methods)
- Phytotherapy
(adverse effects, methods)
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