The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule

NCT03789760 | Completed Phase 3 DMC

• 1 other identifier: SW003
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 29

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.

Conditions

Vascular Dementia

Keywords

Vascular Dementia; cognitive

Outcome Measures

Primary Outcomes (2)

• Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)

  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.

  Change from baseline VaDAS-cog score at Week 52

• Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)

  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).

  Change from baseline ADCS-CGIC score at Week 52

Secondary Outcomes (22)

• Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL)

  Change from baseline ADCS-ADL score at Week 26

• Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL)

  Change from baseline ADCS-ADL score at Week 52

• Mini-mental State Examination(MMSE)

  Change from baseline MMSE score at Week 26

• Mini-mental State Examination(MMSE)

  Change from baseline MMSE score at Week 52

• Clinical Dementia Rating(CDR Scale )

  Change from baseline CDR Scale score at Week 26

Study Arms (2)

active group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

SaiLuoTong capsule DRUG

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.

Also known as: The effects of SaiLuoTong capsule on VaD

active group

placebo DRUG

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.

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; the diameter of each infarct≤ 30mm(And the perivascular spaces and cerebral microbleeds were excluded).
• 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 and lawful guardian prior to the study.
• The subjects must have a care giver who are cognitively normal (MMSE scores: illiteracy\> 17 points, 1 - 6 years of education \> 20 points, 7 years and above of education \> 24 points). The care giver shall also be able to take care of the patient at least 4 days a week for more than 4 hours a day while he or she can accompany the subjects to attend each visit. During the trial, a new caregiver must have MMSE score and the results would be presented in forms of subjects in the attachment.

You may not qualify if:

• 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) level less than 80g/L , platelet count (Plt) level less than 50×109/L, activated partial thromboplastin time (APTT) exceeds 2.5 times the normal upper level, fibrinogen(FIB) level less than 0.5g/L, prothrombin time (PT) exceeds 2.5 times the normal upper level, Serum creatinine (Scr) exceeds 3 times the normal upper level, alanine aminotransferase (ALT) exceed 5 times the normal upper level , aspartate aminotransferase (AST) exceed 5 times the normal upper level, alkaline phosphates (ALP) exceed 5 times the normal upper level , γ-glutamyl transferase (γ-GT) exceed 5 times the normal upper level, total bilirubin (TBiL) exceeds 3 times the normal upper level.
• The subjects have nutritional and metabolic diseases and endocrine system diseases that cannot been controlled by therapy - 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 have been given any drug that can affect the cognitive function (including Chinese herbal preparations containing any one of these: ginseng, ginkgo leaf, and saffron; Western medicines such as donepezil, karbalatine, rivastigmine, huperzine a, memantine and similar drugs, etc; Butylphthalide and other drugs with the same effect such as runeirergine, aniracetam, cytosporine, dihydroergine, nimodipine, etc) within one month before the start of this study and cannot be discontinued.
• 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.

Sponsors & Collaborators

• Shineway Pharmaceutical Co.,Ltd: lead

Study Sites (29)

Xuan Wu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location

Xiyuan Hospital

Beijing, Beijing Municipality, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Location

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067000, China

Location

Handan First Hospital

Handan, Hebei, 056000, China

Location

Hebei Central Hospital of petrochina

Langfang, Hebei, 065000, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

The Fourth Hospital of Medical University

Harbin, Hei Longjiang, China

Location

The First People's Hospital of Luoyang

Luoyang, Henan, 471000, China

Location

The First affiliated Hospital of Nanyang Medical college

Nanyang, Henan, 473000, China

Location

Nanyang Second People's Hospital

Nanyang, Henan, 473003, China

Location

The First Hospital of Changsha

Changsha, Hunan, 41000, China

Location

Xiangya Boai Rehability Hospital

Changsha, Hunan, China

Location

Yueyang Second People's Hospital

Yueyang, Hunan, 414000, China

Location

Baogang Hospital

Baotou, Inner Mongolia, 014000, China

Location

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, China

Location

Taizhou Hospital of Chinese Medicine

Taizhou, Jiangsu, 225300, China

Location

Jiujiang University Clinical Medical College ▪ Jiujiang University Hospital

Jiujiang, Jiangxi, 332000, China

Location

Nanchang Hongdu Hospital of TCM

Nanchang, Jiangxi, China

Location

Changzhi People's Hospital

Changzhi, Shanxi, 046000, China

Location

Jinzhong First People's Hospital

Jinzhong, Shanxi, China

Location

Xianyang Hospital of Yan'an University

Xianyang, Shanxi, 712000, China

Location

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Location

The Second people's Hospital of Neijiang

Neijiang, Sichuan, China

Location

Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300250, China

Location

The Second Hospital of Xingjiang Medical University

Ürümqi, Xingjiang, China

Location

The Central Hospital of Lishui City

Lishui, Zhejiang, 323000, China

Location

MeSH Terms

Conditions

Dementia, Vascular

Interventions

sailuotong

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

  Xuan Wu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 4, 2018
• First Posted: December 31, 2018
• Study Start: April 10, 2019
• Primary Completion: March 12, 2024
• Study Completion: May 19, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (29)