Study on Ginkgo Biolba Extract Fifty and Mild Cognitive Impairment Associated With CSVD

NCT06495476 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-08-28

No results posted yet for this study

Summary

This study aimed to explore the efficacy and safety of Ginkgo Biolba Extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (CSVD). Subjects included based on eligibility criteria were randomized into treatment and control groups. Patients will receive the drug or placebo for 12 months. Patients were followed at baseline and at 3 months, 6 months, and 12 months after randomization. The primary outcome was the difference from baseline in the Montreal Cognitive Assessmen (MoCA) score at 12 months after randomization.

Conditions

Interventions

DRUG

Ginkgo biloba extract 50 dropping pills

Composition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill.

DRUG

Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant

Composition: The main ingredient is polyethylene glycol 6000 + caramel pigment, placebo and ginkgolide drops are basically the same in color, odor and appearance. Size: 10 mg analog ingredient/pill.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-12-31
Completion
2026-06-30

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Entities

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 NCT06495476 on ClinicalTrials.gov