The Clinical Trial of Chinese Herbal Medicine SaiLuoTong Capsule

NCT01978730 | Unknown Phase 2 DMC

• 1 other identifier: SW001
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 16

Brief 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

Keywords

vascular dementia; cognition; stroke

Outcome Measures

Primary Outcomes (2)

• V-ADAS-cog

  The V-ADAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function.

  weeks 0, 13, 26, 39, and 52

• ADCS-CGIC

  The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change.

  weeks 0, 13, 26, 39, and 52

Secondary Outcomes (7)

• ADCS - ADL

  weeks 0, 26, and 52

• MMSE

  screening, weeks 0, 26, and 52

• CDR scale

  screening, weeks 0, 26, and 52

• CLOX

  weeks 0, 26, and 52

• C-EXIT25

  weeks 0, 26, and 52

Study Arms (3)

high dose group of SaiLuoTong capsule

EXPERIMENTAL

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: high dose group of SaiLuoTong capsule

low dose group of SaiLuoTong capsule

EXPERIMENTAL

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: low dose group of SaiLuoTong

the control group

PLACEBO COMPARATOR

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.

Drug: the control group

Interventions

high dose group of SaiLuoTong capsule DRUG

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.

high dose group of SaiLuoTong capsule

low dose group of SaiLuoTong DRUG

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.

low dose group of SaiLuoTong capsule

the control group DRUG

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.

the control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or above, gender is not limited;
• Education≥primary-school;
• Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria;
• Probable VaD diagnosed by the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences(NINDS-AIREN) criteria;
• Modified Hachinski ischemic scale(MHIS) total score≥4;
• Evidence of ischemic cerebrovascular disease on magnetic resonance imaging (MRI)and /or CT (corresponding with the imaging criteria of NINDS-AIREN)
• Mild-to-moderate dementia defined by MMSE score between 10 and 26, CDR score between 1 and 2, both inclusive
• Modified Hachinski ischemic scale(MHIS) total score≥4;
• Hamilton depression scale (HAMD) total score≤17;
• The patients agree to participate in the study and able to understand informed consent as well as signing it. In cases where patients are unable to do so, carer's consent will be obtained as proxy;
• There are carers accompanying patients at least 4 days a week and can accompany patients to participate in each visit.

You may not qualify if:

• Dementia caused by other brain diseases except VaD (e.g. Alzheimer's disease, Lewy body dementia, frontotemporal dementia, Parkinson's disease, demyelinated disease of the central nervous system, tumour, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome, etc.);
• The patient who can not complete examination because of severe brain or nerve function loss, such as convenient hand hemiplegia, all sorts of aphasia and audio-visual obstacles, etc;
• The presence of abnormal laboratory parameters: Hemoglobin (Hb) and platelet (Plt)less than the lower limit; activated partial thromboplastin time (APTT) beyond the normal value more than 10 seconds, prothrombin time (PT) beyond the normal value more than 3 seconds; creatinine (Cr) more than 1.5 times the upper limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphates (ALP), γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal, total bilirubin (TBiL) more than 1.5 times the upper limit of normal;
• Nutrition metabolic diseases and endocrine system lesions such as thyroid disease, parathyroid diseases,and deficiency of vitamins or other elements;
• Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases (such as unstable angina, incontrollable asthma, active bleeding, etc.) and cancer;
• Severe mental illness (such as depression, schizophrenia) and epilepsy;
• Gastrointestinal disorders that affect drug absorption, distribution, and metabolism;
• Alcohol and drug abuse;
• Patients who are using and cannot stop the following drugs including Chinese herba preparation containing ginseng, ginkgo leaf or any component of the saffron; medications that may affect cognitive functioning, such as donepezil, rivastigmine, huperzine A, memantine, nimodipine; etc.;
• Known to be allergic to the composition of SaiLuoTong;
• Pregnancy or breast-feeding women;
• New strokes within 3 months before baseline
• Had participated in other clinical trials before this study 3 months prior to this study.

Sponsors & Collaborators

• Shineway Pharmaceutical Co.,Ltd: lead

Study Sites (16)

Dongzhimen Hospital affiliated to Beijing University of Chinese Traditional Medicine

Beijing, Beijing Municipality, 100007, China

Location

Beijing Friendship Hospital of Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Xuan Wu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

The Chinese Traditional Medical Hospital of Guangdong Province

Guangzhou, Guangdong, 510006, China

Location

Southern Hospital of Southern Medical

Guangzhou, Guangdong, 510515, China

Location

The First Hospital of Hunan University of Chinese Traditional Medicine

Changsha, Hunan, 410007, China

Location

The First people's Hospital of Chenzhou

Chenzhou, Hunan, 423000, China

Location

The Central Hospital of Baotou

Baotou, Inner Mongolia, 014040, China

Location

The Zhongda Hospital of Southeast University

Nanjing, Jiangsu, 210009, China

Location

Chinese Traditional Medical Hospital of Jiangsu Province

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The Hospital of Traditional Chinese and Western Medicine of Jilin Province

Changchun, Jilin, 132012, China

Location

The Shuguang Hospital of Shanghai University of Chinese Traditional Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

The Affiliated Hospital of Chengdu Chinese Traditional Medicine

Chengdu, Sichuan, 610072, China

Location

The First Hospital of Tianjin University of Chinese Traditional Medicine

Tianjin, Tianjin Municipality, 300193, China

Location

The First Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Dementia, Vascular; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jianping Jia, professor

  the chief of the neurology department, Xuan Wu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

• Baojun Wang, Doctor

  the chief of of the neurology department, Central Hospital of Baotou

  STUDY CHAIR

• Yingzhen Xie, Doctor

  the chief of the neurology department, Dongzhimen Hospital

  STUDY CHAIR

• Yuangao Liao, Doctor

  the chief of the neurology department, the First people's Hospital of Chenzhou

  STUDY CHAIR

• Dongdong Yang, Doctor

  the chief of the neurology department, the Affiliated Hospital of Chengdu Chinese Traditional Medicine

  STUDY CHAIR

• Zhijun Zhang, Doctor

  the chief of the neurology department, Zhongda Hospital of Southeast University

  STUDY CHAIR

• Yefeng Cai, Master

  the chief of the neurology department, Chinese Traditional Medical Hospital of Guangdong Province

  STUDY CHAIR

• Desheng Zhou, Doctor

  the chief of the neurology department, First Hospital of Hunan University of Chinese Traditional Medicine

  STUDY CHAIR

• Jiang Wu, Doctor

  the chief of the neurology department, the First Hospital of Jilin University

  STUDY CHAIR

• Changshan Ai, Master

  the chief of the neurology department, Hospital of Traditional Chinese and Western Medicine of Jilin Province

  STUDY CHAIR

• Yajun Jiang, Doctor

  the chief of the neurology department, Chinese Traditional Medical Hospital of Jiangsu Province

  STUDY CHAIR

• Wei Xie, Doctor

  the chief of the neurology department, Southern Hospital of Southern Medical University

  STUDY CHAIR

• Xiaofei Yu

  the chief of the neurology department, Shuguang Hospital of Shanghai University of Chinese Traditional Medicine

  STUDY CHAIR

• Jimei Li, Bachelor

  the chief of the neurology department, Beijing Friendship Hospital of Capital Medical University

  STUDY CHAIR

• Jianming Lv

  the chief of the neurology department, the First Hospital of Tianjin University of Chinese Traditional Medicine

  STUDY CHAIR

• Benyan Luo, Doctor

  the chief of the neurology department, the First Hospital of Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: December 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

CN (16)