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The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule

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ClinicalTrials.gov Identifier: NCT03789760
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Shineway Pharmaceutical Co.,Ltd

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). According to the result of the phase II study, the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. So the study hypothesis is also 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 confirm 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 or disease Intervention/treatment Phase
Vascular Dementia Drug: SaiLuoTong capsule Drug: placebo Phase 3

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. The result of the phase II study showed that the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. Based on these previous evidences, the investigators conduct this study to further confirm the efficacy and safety of SaiLuoTong capsule in patients with mild to moderate VaD. This study is a phase III clinical trial of SaiLuoTong capsule for treatment of vascular dementia. The study is a 52-week, multicentre, randomized, double -blind, placebo-controlled study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel, and Multi-centre Study to Evaluate the Clinical Efficacy and Safety of SaiLuoTong (SLT) in the Treatment of Vascular Dementia
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: active group
take two pills (120 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.
Drug: SaiLuoTong capsule
500 subjects are randomly divided into two groups by 3:1. 375 subjects in the active group take two pills(120mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.
Other Name: The effects of SaiLuoTong capsule on VaD

Placebo Comparator: control group
take two pills (120 mg) of placebo each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.
Drug: placebo
500 subjects are randomly divided into two groups by 3:1. 125 subjects in the control group take two pills(120mg) of placebo each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.




Primary Outcome Measures :
  1. Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) [ Time Frame: Change from baseline VaDAS-cog score at Week 52 ]
    The VaDAS-cog comprises the Alzheimer's disease assessment scale(ADAS-cog) plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 52.

  2. Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) [ Time Frame: Change from baseline ADCS-CGIC score at Week 52 ]
    The Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(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. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).


Secondary Outcome Measures :
  1. Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL) [ Time Frame: Change from baseline ADCS-ADL score at Week 26 ]
    To assess the daily living activity of the patients, including a subgroup in which there are 23 items to be checked and the total score is 78. A higher score represents a better daily living activity, vice versa. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean,SD) of precise scores at week 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.

  2. Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL) [ Time Frame: Change from baseline ADCS-ADL score at Week 52 ]
    To assess the daily living activity of the patients, including a subgroup in which there are 23 items to be checked and the total score is 78. A higher score represents a better daily living activity, vice versa. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean,SD) of precise scores at week 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.

  3. Mini-mental State Examination(MMSE) [ Time Frame: Change from baseline MMSE score at Week 26 ]
    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. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean, SD) of precise scores at screening (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.

  4. Mini-mental State Examination(MMSE) [ Time Frame: Change from baseline MMSE score at Week 52 ]
    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. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean, SD) of precise scores at screening (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.

  5. Clinical Dementia Rating(CDR Scale ) [ Time Frame: Change from baseline CDR Scale score at Week 26 ]
    The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Talk to the patients or those who know well about the patients and assess the 6 functions (memory, orientation, judgment and problem-solving ability, social activities, household duties and hobbies as well as self-care ability) to obtain the scores and based on the predetermined principles the CDR score is calculated. The diagnostic criteria[68]: normal-CDR=0; suspected dementia-CDR=0.5, mild dementia-CDR=1; moderate dementia- CDR=2; and serious dementia-CDR=3. The data in the table below is the statistical data (mean, SD) of precise scores at baseline and weeks 26.

  6. Clinical Dementia Rating(CDR Scale ) [ Time Frame: Change from baseline CDR Scale score at Week 52 ]
    The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Talk to the patients or those who know well about the patients and assess the 6 functions (memory, orientation, judgment and problem-solving ability, social activities, household duties and hobbies as well as self-care ability) to obtain the scores and based on the predetermined principles the CDR score is calculated. The diagnostic criteria[68]: normal-CDR=0; suspected dementia-CDR=0.5, mild dementia-CDR=1; moderate dementia- CDR=2; and serious dementia-CDR=3. The data in the table below is the statistical data (mean, SD) of precise scores at baseline and weeks 52.

  7. Clinical Dementia Rating sum of boxes(CDR-sb) [ Time Frame: Change from baseline CDR-sb score at Week 26 ]
    CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment. CDR-sb is the algebraic sum of 6 functional domains with a range of 0(normal) - 18(severe dementia). The data in the table below is the statistical data (mean,SD) of precise scores at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.

  8. Clinical Dementia Rating sum of boxes(CDR-sb) [ Time Frame: Change from baseline CDR-sb score at Week 52 ]
    CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment. CDR-sb is the algebraic sum of 6 functional domains with a range of 0(normal) - 18(severe dementia). The data in the table below is the statistical data (mean,SD) of precise scores at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.

  9. Blood biomarker: Brain-derived neurotrophic factor(BDNF) [ Time Frame: Change from baseline BDNF at Week 26 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.

  10. Blood biomarker: Brain-derived neurotrophic factor(BDNF) [ Time Frame: Change from baseline BDNF at Week 52 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0(baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.

  11. Blood biomarker: Vascular endothelial growth factor(VEGF) [ Time Frame: Change from baseline VEGF at Week 26 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.

  12. Blood biomarker: Vascular endothelial growth factor(VEGF) [ Time Frame: Change from baseline VEGF at Week 52 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.

  13. Blood biomarker: Matrix metalloproteinase-9(MMP-9) [ Time Frame: Change from baseline MMP-9 at Week 26 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.

  14. Blood biomarker: Matrix metalloproteinase-9(MMP-9)) [ Time Frame: Change from baseline MMP-9 at Week 52 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.

  15. Blood biomarker: Interleukin-6(IL-6) [ Time Frame: Change from baseline MMP-9 at Week 26 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.

  16. Blood biomarker: Interleukin-6(IL-6) [ Time Frame: Change from baseline MMP-9 at Week 52 ]
    The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.

  17. Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) [ Time Frame: Change from baseline VaDAS-cog score at week 13 ]
    The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 13.

  18. Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) [ Time Frame: Change from baseline VaDAS-cog score at week 26 ]
    The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 26.

  19. Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) [ Time Frame: Change from baseline VaDAS-cog score at week 39 ]
    The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 39.

  20. Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) [ Time Frame: Change from baseline ADCS-CGIC score at week 13 ]
    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. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).

  21. Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) [ Time Frame: Change from baseline ADCS-CGIC score at week 26 ]
    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. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).

  22. Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) [ Time Frame: Change from baseline ADCS-CGIC score at week 39 ]
    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. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 years≤Age≤75 years, female or male.
  • With an education at more than (including) 6 years.
  • Meet the diagnostic criteria for dementia in Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V).
  • Meet the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche etl'Enseignement en Neurosciences(NINDS-AIREN) Criteria of Probable Vascular Dementia (1993).
  • MRI (magnetic resonance imaging) supports the presence of ischemic cerebrovascular disease, and meets NINDS-AIREN Imaging Criteria (2mm ≤the diameter of each infarct≤ 30mm and 1≤the number of infarcts≤ 6).
  • Modified Hachinski Ischemic (mHIS) Scale ≥ 4.
  • Hamilton depression scale (HAMD) ≤ 17.
  • Patients with mild or moderate VaD: 10 ≤ MMSE ≤ 26 and 1 ≤ CDR ≤ 2.
  • Willing to participate in this study and could sign the informed consent form by him/herself or lawful guardian prior to the study.
  • Have caregivers; the MMSE scores of caregivers should be within the following range: illiteracy> 17 points, 1 - 6 years of education > 20 points, 7 years and above of education > 24 points; can accompany patients at least 4 days per week, at least 4 hours per day and each follow-up visit.

Exclusion Criteria:

  • Patients with dementia caused by a brain disease other than VaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, central nervous system demyelinative diseases, tumour, hydrocephalus, trauma, central nervous system infection, such as syphilis, AIDS and Creutzfeldt-Jakob disease);
  • Patients with serious neurological impairment to finish the examination: hand hemiplegia, aphasia, and visual or hearing impairment.
  • Laboratory anomalies: hemoglobin (Hb) and platelet count (Plt) levels less than normal lower limit, activated partial thromboplastin time (APTT) exceeds the normal control value by over 10 s, prothrombin time (PT) exceeds the normal control value by over 3 s, creatinine (Cr) exceeds 1.5 times the normal upper level, alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphates (ALP), and γ-glutamyl transferase (γ-GT) exceed twice the normal upper level, total bilirubin (TBiL) exceeds 1.5 times the normal upper level.
  • Nutritional and metabolic diseases and endocrine system diseases: thyroid diseases, parathyroid disease, vitamin or element deficiency.
  • Patients with serious circulatory system diseases, respiratory system diseases, urinary system diseases, digestive system diseases, haemopoietic system diseases (such as unstable angina, uncontrollable asthma and active gastrorrhagia) and cancer.
  • Serious mental disease (such as depression and schizophrenia) and epilepsy.
  • Gastrointestinal diseases that may affect the absorption, distribution, and metabolism of the investigational drug.
  • Alcohol and drug abuse.
  • Patients who are on drugs that cannot be discontinued (including Chinese herbal preparations containing any one of these: ginseng, ginkgo leaf, and saffron; Western medicines such as donepezil, rivastigmine, huperzine a, memantine, and nimodipine).
  • Patients who are allergic to more than 2 drugs or any component of the SLT capsules.
  • Pregnant or lactating women.
  • Patients who have participated in other clinical studies within 3 months prior to this study.
  • Cannot accept magnetic resonance imaging (MRI) examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789760


Contacts
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Contact: Jianping Jia, Professor 13911052899 ext 010-83108650 jiajp@vip.126.com

Locations
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China, Beijing
Xuan Wu Hospital of Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Jianping Jia, Professor    13911052899    jiajp@vip.126.com   
Peking University Shougang Hospital Recruiting
Beijing, Beijing, China, 100144
Contact: Wei Gao    13161380278    gaowei3@sina.com   
China, Hebei
Affiliated Hospital of Chengde Medical College Recruiting
Chengde, Hebei, China, 067000
Contact: Liang Zhao    15633142910    liangzhao@163.com   
Handan First Hospital Recruiting
Handan, Hebei, China, 056000
Contact: Liping Cheng    15932040963    clp717@126.com   
The Third Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050051
Contact: Liu Junyan    18533112972    junyanliu2003@163.com   
China, Henan
The First People's Hospital of Luoyang Recruiting
Luoyang, Henan, China, 471000
Contact: Sujuan Wang    18538882081    13629803626@163.com   
China, Hunan
The First Hospital of Changsha Recruiting
Changsha, Hunan, China, 41000
Contact: Wang Aimin    13873188716    13871388716@163.com   
China, Inner Mongolia
Baogang Hospital Recruiting
Baotou, Inner Mongolia, China, 014000
Contact: Yang Yueming    13847207094    13847207094@163.com   
China, Jiangsu
Taizhou Hospital of Chinese Medicine Recruiting
Taizhou, Jiangsu, China, 225300
Contact: Quan Yaping    13401233118    quanyaping1@126.com   
China, Jiangxi
Jiujiang University Clinical Medical College ▪ Jiujiang University Hospital Recruiting
Jiujiang, Jiangxi, China, 332000
Contact: Hongbing Nie    13607927780    niehongbin1@126.com   
China, Shanxi
Xianyang Hospital of Yan'an University Recruiting
Xianyang, Shanxi, China, 712000
Contact: Wang Shaojun    13759850235    wsj12520@sohu.com   
China, Zhejiang
Wenzhou Hospital of Traditional Chinese Medicine Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Ling Chen    13868403777    chinglingp@163.com   
Sponsors and Collaborators
Shineway Pharmaceutical Co.,Ltd
Investigators
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Principal Investigator: Jianping Jia, Professor Xuan Wu Hospital of Capital Medical University

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Responsible Party: Shineway Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT03789760     History of Changes
Other Study ID Numbers: SW003
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shineway Pharmaceutical Co.,Ltd:
Vascular Dementia
cognitive
Additional relevant MeSH terms:
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Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases