The Clinical Trial of Chinese Herbal Medicine SaiLuoTong Capsule

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.

Conditions

• Vascular Dementia

Interventions

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.

Sponsors & Collaborators

• Shineway Pharmaceutical Co.,Ltd

  lead INDUSTRY

Principal Investigators

• Jianping Jia, professor · the chief of the neurology department, Xuan Wu Hospital of Capital Medical University

• Baojun Wang, Doctor · the chief of of the neurology department, Central Hospital of Baotou

• Yingzhen Xie, Doctor · the chief of the neurology department, Dongzhimen Hospital

• Yuangao Liao, Doctor · the chief of the neurology department, the First people's Hospital of Chenzhou

• Dongdong Yang, Doctor · the chief of the neurology department, the Affiliated Hospital of Chengdu Chinese Traditional Medicine

• Zhijun Zhang, Doctor · the chief of the neurology department, Zhongda Hospital of Southeast University

• Yefeng Cai, Master · the chief of the neurology department, Chinese Traditional Medical Hospital of Guangdong Province

• Desheng Zhou, Doctor · the chief of the neurology department, First Hospital of Hunan University of Chinese Traditional Medicine

• Jiang Wu, Doctor · the chief of the neurology department, the First Hospital of Jilin University

• Changshan Ai, Master · the chief of the neurology department, Hospital of Traditional Chinese and Western Medicine of Jilin Province

• Yajun Jiang, Doctor · the chief of the neurology department, Chinese Traditional Medical Hospital of Jiangsu Province

• Wei Xie, Doctor · the chief of the neurology department, Southern Hospital of Southern Medical University

• Xiaofei Yu · the chief of the neurology department, Shuguang Hospital of Shanghai University of Chinese Traditional Medicine

• Jimei Li, Bachelor · the chief of the neurology department, Beijing Friendship Hospital of Capital Medical University

• Jianming Lv · the chief of the neurology department, the First Hospital of Tianjin University of Chinese Traditional Medicine

• Benyan Luo, Doctor · the chief of the neurology department, the First Hospital of Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• China

Study Locations