The Clinical Trial of Chinese Herbal Medicine SaiLuoTong Capsule

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shineway Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01978730
First received: October 31, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Vascular Dementia
Drug: high dose group of SaiLuoTong capsule
Drug: low dose group of SaiLuoTong
Drug: the control group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shineway Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • V-ADAS-cog [ Time Frame: weeks 0, 13, 26, 39, and 52 ] [ Designated as safety issue: No ]
    The V-ADAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function.

  • ADCS-CGIC [ Time Frame: weeks 0, 13, 26, 39, and 52 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • ADCS - ADL [ Time Frame: weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    An inventory to assess the patient's ability to do basic activities of daily living and instrumental activities of daily living.

  • MMSE [ Time Frame: screening, weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    The MMSE is a global test of cognitive function, for which the total score ranges from 0 to 30, with higher scores indicating lesser severity.

  • CDR scale [ Time Frame: screening, weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage').

  • CLOX [ Time Frame: weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    It was designed to elicit executive impairment and to discriminate it from non-executive constructional failure.

  • C-EXIT25 [ Time Frame: weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    The C-EXIT25 is a measure of executive function based on a 15-min interview addressing 25 items related to executive cognition.

  • NPI [ Time Frame: weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    The NPI is used to assess neuropsychiatric symptoms. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions.

  • CDR-sb [ Time Frame: weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment.


Estimated Enrollment: 372
Study Start Date: December 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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: 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.
Experimental: 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: 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.
Placebo Comparator: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978730

Locations
China, Beijing
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing, China, 100050
Dongzhimen Hospital affiliated to Beijing University of Chinese Traditional Medicine
Beijing, Beijing, China, 100007
Xuan Wu Hospital of Capital Medical University
Beijing city, Beijing, China, 100053
China, Guangdong
Southern Hospital of Southern Medical
Guangzhou, Guangdong, China, 510515
The Chinese Traditional Medical Hospital of Guangdong Province
Guangzhou city, Guangdong, China, 510006
China, Hunan
The First Hospital of Hunan University of Chinese Traditional Medicine
Changsha, Hunan, China, 410007
The First people's Hospital of Chenzhou
Chenzhou, Hunan, China, 423000
China, Inner Mongolia
The Central Hospital of Baotou
Baotou city, Inner Mongolia, China, 014040
China, Jiangsu
Chinese Traditional Medical Hospital of Jiangsu Province
Nanjing, Jiangsu, China, 210029
The Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China, 210009
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
The Hospital of Traditional Chinese and Western Medicine of Jilin Province
Changchun, Jilin, China, 132012
China, Shanghai
The Shuguang Hospital of Shanghai University of Chinese Traditional Medicine
Shanghai, Shanghai, China, 201203
China, Sichuan
The Affiliated Hospital of Chengdu Chinese Traditional Medicine
Chengdu, Sichuan, China, 610072
China, Tianjin
The First Hospital of Tianjin University of Chinese Traditional Medicine
Tianjin, Tianjin, China, 300193
China, Zhejiang
The First Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Shineway Pharmaceutical Co.,Ltd
Investigators
Principal Investigator: Jianping Jia, professor the chief of the neurology department, Xuan Wu Hospital of Capital Medical University
Study Chair: 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
  More Information

No publications provided

Responsible Party: Shineway Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01978730     History of Changes
Other Study ID Numbers: SW001
Study First Received: October 31, 2013
Last Updated: May 7, 2014
Health Authority: China: Ethics Committee
China: Food and Drug Administration

Keywords provided by Shineway Pharmaceutical Co.,Ltd:
vascular dementia
cognition
stroke

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014