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Can an herbal capsule boost memory in dementia patients?

NCT ID NCT03789760

Symptom relief Sponsor: Shineway Pharmaceutical Co.,Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a traditional Chinese medicine capsule called SaiLuoTong (SLT) in 493 adults aged 40-75 with mild to moderate vascular dementia. The goal was to see if SLT improves thinking, memory, daily activities, and behavior compared to a placebo. The trial lasted 52 weeks and also checked for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

493 people

The number who actually took part.

Started

Apr 2019

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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; 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. 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) 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.

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Conditions

The condition(s) this trial relates to.

vascular dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vascular dementia

Contacts and locations

Locations

  • Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067000, China

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, China

  • Baogang Hospital

    Baotou, Inner Mongolia, 014000, China

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000, China

  • Handan First Hospital

    Handan, Hebei, 056000, China

  • Hebei Central Hospital of petrochina

    Langfang, Hebei, 065000, China

  • Inner Mongolia International Mongolian Hospital

    Hohhot, Inner Mongolia, China

  • Jinzhong First People's Hospital

    Jinzhong, Shanxi, China

  • Jiujiang University Clinical Medical College ▪ Jiujiang University Hospital

    Jiujiang, Jiangxi, 332000, China

  • Nanchang Hongdu Hospital of TCM

    Nanchang, Jiangxi, China

  • Nanyang Second People's Hospital

    Nanyang, Henan, 473003, China

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100144, China

  • Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300250, China

  • Taizhou Hospital of Chinese Medicine

    Taizhou, Jiangsu, 225300, China

  • The Central Hospital of Lishui City

    Lishui, Zhejiang, 323000, China

  • The First Hospital of Changsha

    Changsha, Hunan, 41000, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000, China

  • The First People's Hospital of Luoyang

    Luoyang, Henan, 471000, China

  • The First affiliated Hospital of Nanyang Medical college

    Nanyang, Henan, 473000, China

  • The Fourth Hospital of Medical University

    Harbin, Hei Longjiang, China

  • The Second Hospital of Xingjiang Medical University

    Ürümqi, Xingjiang, China

  • The Second people's Hospital of Neijiang

    Neijiang, Sichuan, China

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051, China

  • Xiangya Boai Rehability Hospital

    Changsha, Hunan, China

  • Xianyang Hospital of Yan'an University

    Xianyang, Shanxi, 712000, China

  • Xiyuan Hospital

    Beijing, Beijing Municipality, China

  • Xuan Wu Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100053, China

  • Yueyang Second People's Hospital

    Yueyang, Hunan, 414000, China

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.