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The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule

NCT03789760 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Shineway Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jianping Jia, Professor · Xuan Wu Hospital of Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2024-03-12
Completion
2024-05-19

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789760 on ClinicalTrials.gov