NCT01978730

The Clinical Trial of Chinese Herbal Medicine SaiLuoTong Capsule

Phase 2 Clinical Trial of SaiLuoTong Capsule for Vascular Dementia：A 26-week, Multicentre, Randomized, Double -Blind, Placebo-controlled Trial With a 26-week Open-label Extension

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Shineway Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). The study hypothesis is that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to determine the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.

Detailed description

Vascular dementia (VaD) is a clinical syndrome of acquired intellectual and functional impairment that results from cerebrovascular diseases. SaiLuoTong capsule is a traditional Chinese medicine compound; it is composed of ginseng extract (the main composition: ginseng total saponins), ginkgo biloba extract (the main composition: YinXingTong ester) and safflower extract (the main composition: the west safflower total glycosides). The function of SaiLuoTong capsule is Yiqi Huoxue and Huayu Tongluo in Chinese traditional medicine theory. Pharmacodynamics studies showed that SaiLuoTong capsule can significantly improve neurological symptoms caused by focal cerebral ischemia in animals, and learning and memory ability in animal models of VaD. Based on these previous evidences, we conduct this study to assess the efficacy and safety of SaiLuoTong capsule in patients with mild to moderate VaD. This study is a phase 2 clinical trial of SaiLuoTong capsule for treatment of vascular dementia. The initial study is a 26-week, multicentre, randomized, double -blind, placebo-controlled study. Patients who complete the initial 26-week trial will be eligible to continue in a 26-week open-label extension study. The primary and secondary objectives of this study are as following: Primary Objectives: 1. To assess the efficacy of SaiLuoTong capsule on cognitive and global functioning in patients with mild-to-moderate VaD; 2. To assess the safety and tolerability of SaiLuoTong capsule in patients with mild-to-moderate VaD. Secondary Objectives: 1. To assess the efficacy of SaiLuoTong capsule in improving the ability to do activities of daily living, executive function, and neuropsychiatric symptoms in patients with mild-to-moderate VaD; 2. To assess the efficacy of different dosage regimens of SaiLuoTong in patients with mild-to-moderate VaD; 3. To assess the efficacy of SaiLuoTong treatment of different duration in patients with mild-to-moderate VaD; 4. To assess the efficacy of SaiLuoTong capsule on different etiological subtypes of VaD, including large-vessel VaD, small-vessel VaD, and VaD of mixed large-vessel and small-vessel origin; 5. To assess the efficacy of SaiLuoTong capsule in mild VaD patients and moderate VaD patients separately; 6. To assess to effect of apolipoprotein E (ApoE) ε4 allele on trial outcomes. The study will assess the changes in cognitive function, daily living skills, executive functions, behavioral and psychological symptoms. The primary measures of effectiveness include the change from baseline in the vascular dementia assessment scale cognitive subscale (V-ADAS-cog) and Alzheimer's disease cooperative study-clinical global impression of change (ADCS-CGIC). Secondary measures of effectiveness include the change from baseline in the Alzheimer's disease cooperative study-activities of daily living inventory (ADCS-ADL), mini-mental state examination (MMSE), clinical dementia rating scale (CDR), sum of boxes of CDR(CDR-sb), clock drawing task (CLOX), Chinese version of executive interview 25 (C-EXIT25) and neuropsychiatric inventory (NPI). Safety measures include physical examinations, vital signs, electrocardiography, laboratory tests, and adverse events records.

Conditions

• Vascular Dementia

Interventions

Type	Name	Description
DRUG	high dose group of SaiLuoTong capsule	high dose group of SaiLuoTong capsule: take three pills (180 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.
DRUG	low dose group of SaiLuoTong	low dose group of SaiLuoTong capsule: take two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.
DRUG	the control group	The control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-11-07
• Last updated: 2014-05-08

Locations

16 sites across 1 country: China