Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to moderate vascular dementia in a more reasonable design.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05371639

Vascular Dementia Cognitive Impairment

UNKNOWN PHASE2

Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

NCT03230071

Vascular Dementia

COMPLETED PHASE2

A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

NCT01404169

Alzheimer's Type Dementia

COMPLETED PHASE3

Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney)

NCT06534723

Alzheimer's Dementia

RECRUITING PHASE3

Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease

NCT02787746

Alzheimer's Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a 24-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase III trial being carried out in 23 centers around China. The study population includes mild to moderate VaD patients (planned a total of 630) aged 45-85 in both gender. Participants will be randomly allocated to TZK (15g/d) and placebo identified to donepezil, donepezil (5mg/d) and placebo identified to TZK, or placebo identified to TZK and placebo identified to donepezil for a 24-weeks double-blind treatment period . The primary outcome measure is change from baseline in the Vascular Dementia Assessment Scale-Cognitive Subscale and Clinician's Interview-Based Impression of Change-Plus carer Interview. The secondary outcomes are changes from baseline in the Mini-Mental State Examination, Activity of Daily Living Scale, Clock Drawing Test, Trail Making Test and Neuropsychiatric Inventory. Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tianzhi granule

Tianzhi granule and placebo identified to donepezil

Group Type EXPERIMENTAL

Tianzhi granule and placebo identified to donepezil

Intervention Type DRUG

1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks

Donepezil

Donepezil and placebo identified to Tianzhi granule

Group Type ACTIVE_COMPARATOR

Donepezil and placebo identified to Tianzhi granule

Intervention Type DRUG

donepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks

Placebo

Placebo identified toTianzhi granule and placebo identified to donepezil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tianzhi granule and placebo identified to donepezil

1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks

Intervention Type DRUG

Donepezil and placebo identified to Tianzhi granule

donepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks

Intervention Type DRUG

Placebo

placebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Inpatients and outpatients meeting the diagnostic criteria probable VaD established according to the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) （DSM-Ⅳ） and the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN)were eligible to participate,
* diagnosis of mild to moderate vascular dementia;
* Chinese-speaking patients aged ≥45 and≤85 years old in both gender;
* weighing between 45 and 90kg;
* fully conscious;
* MMSE score of≤26 and ≥14;
* HIS score of ≥7;
* adequate vision and hearing ability to complete all study tests;
* with a stable caregiver.

Exclusion Criteria

Patients will be excluded from the enrollment if they meet any of the followings:

* a medical history of other dementia types, like Alzheimer's disease, Parkinson's disease dementia, Huntington disease, Normal pressure hydrocephalus, et al;
* major depression (HAMD for 17 items\>17) or psychotic disorder;
* acute stage of cerebral hemorrhage or subarachnoid hemorrhage;
* hypothyroidism;
* drug or alcohol abuse;
* epilepsy history; myasthenia gravis history;
* severe cardiovascular disease(severe arrhythmia with heart rate≥100 or≤60 times per min, left bundle branch block, myocardial infarction within 3 months, systolic pressure≥180mmHg or ≤90mmHg);
* severe liver or kidney dysfunction (alanine aminotransferase\>60 IU/L, aspartate transaminase\>60 IU/L or serum creatinine \>266μmol/L);
* severe asthma or chronic obstructive pulmonary disease;
* gastrointestinal tract obstruction or severe peptic ulcer; glaucoma;
* administration of cholinesterase inhibitors, memantine or nimodipine in the last month;
* use of sympathomimetic agent, antihistamine drug, antianxiety drugs or tranquilizer within 48h before assessment;
* use of antipsychotic drugs within 72h before assessment;
* participation in other clinical trials; allergic history to any type of medication used in this study.

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No