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NCT03789760

The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule

Completed Phase 3 Last updated 17 February 2026
What this trial tests

Phase 3 trial testing SaiLuoTong capsule in Vascular Dementia in 493 participants. Completed in 19 May 2024.

Timeline
10 April 2019
Primary endpoint
12 March 2024
19 May 2024

Quick facts

Lead sponsorShineway Pharmaceutical Co.,Ltd
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment493
Start date10 April 2019
Primary completion12 March 2024
Estimated completion19 May 2024
Sites29 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Shineway Pharmaceutical Co.,Ltd — full company profile →

Who can join

Adults 40 to 75, any sex, with Vascular Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Trials of New Drugs for Vascular Cognitive Impairment and Vascular Dementia.
    Linh TTD, Hsieh YC, Huang LK, Hu CJ. · · 2022 · cited 39× · PMID 36232368 · DOI 10.3390/ijms231911067

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