MedTrace Logo

Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in Mild to Moderate Vascular Dementia

NCT05371639 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-11-22

No results posted yet for this study

Summary

The study will be a 36-week multicentre, double-blind, placebo-controlled phase Ⅱb trial in China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi Gan group (84mg per day) or to placebo group. The primary endpoint will be Vascular Dementia Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of Boxes. Secondary outcomes included changes in Mini-Mental State Examination, Clock Drawing Test, Delayed Story Recall and Ability of Daily Living. Patients' safety will be assessed by recording of adverse events, clinical examinations, electrocardiography and laboratory tests. The patients, caregivers, and investigators will be blinded to the treatment allocations.

Conditions

Interventions

DRUG

Tian Ma Bian Chun Zhi Gan Tablets

Tian Ma Bian Chun Zhi Gan Tablets, 0.1g per pill which contains 14mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks.

DRUG

Placebo

Placebo identified to Tian Ma Bian Chun Zhi Gan, 0.1g per pill which contains 0mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks.

Sponsors & Collaborators

  • Dongzhimen Hospital, Beijing

    lead OTHER

Principal Investigators

  • Jinzhou Tian · Dongzhimen Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05371639 on ClinicalTrials.gov