Back to results

Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia

Primary Purpose

Vascular Dementia

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fufangdanshen Tablets

Placebo

About this trial

This is an interventional treatment trial for Vascular Dementia focused on measuring Vascular dementia, Fufangdanshen Tablets, Randomized Controlled trial, Chinese Medicine

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
Weighing between 45 to 90 kg;
The diagnosis had also to be compatible with the findings from a recent (within last 12 months) magnetic resonance image (MRI) of the brain and
The Hachinski Ischemia Scale (HIS) score>4.
six months' mild to moderate VaD duration before inclusion.
Mild-to-moderate dementia (Score of the Mini-Mental State Examination (MMSE) defined as between 11 to 26)
The Hamilton Depression Scale (HAMD for 17 items) had a score of ≤ 12
have a consistent informant to accompany them on scheduled visits
Ability to read, write, communicate, and understand cognitive testing instructions

Exclusion Criteria:

Neurodegenerative disorders such as Parkinson's disease, with AD and any other secondary types of dementia;
cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor
having significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
history of epilepsy, convulsions, drug abuse or alcohol abuse
history of hypersensitivity to the treatment drugs;
concomitant drugs with the potential to interfere with cognition;
administration of other investigational drugs;
females of child bearing potential without adequate contraception

Sites / Locations

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fufangdanshen Tablets

Placebo

Arm Description

1 tablets contains contains tanshinoneⅡA 0.67mg , salvianolic acid B 8.2mg, Panax Notoginsenosides R1 0.53mg, ginsenoside Rb1 3.03mg, ginsenoside Rg1 2.73mg, 3 tablets per time, 3 times per day for 24 weeks

3 tablets per time, 3 times per day for 24 weeks. The placebo has similar smile and appearance as the Fufangdanshen Tablets

Outcomes

Primary Outcome Measures

Change from baseline to end of double-blind treatment Clinician's Interview Based Impression of Change - Plus Caregiver Input; Alzheimer Disease Assessment Scale-cognitive subscale

Global cognition was assessed with the CIBIC-plus, at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive. subscale (ADAS-cog)

Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Secondary Outcome Measures

Change in functional scores: Activities of Daily Living (ADL).

Functional ability was evaluated with the ADL was evaluated at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24).

Change from baseline to the end of double-blind treatment in Mini-mental state examination (MMSE) scores

Change in global cognition:Mini-mental state examination at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Full Information

NCT ID

NCT01761227

First Posted

January 2, 2013

Last Updated

October 22, 2018

Sponsor

Dongzhimen Hospital, Beijing

Collaborators

Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT01761227

Brief Title

Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia

Official Title

The Safety and Efficacy of Fufangdanshen Tablets in Treatment of Mild to Moderate Vascular Dementia: a 24-week, Double Blind, Randomized, Parallel,Placebo Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 2012 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dongzhimen Hospital, Beijing

Collaborators

Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Purpose: The purpose of this study is to examine the efficacy and safety of Fufangdanshen Tablets in patients with mild to moderate vascular dementia (VaD).

Detailed Description

This multicenter, double-blind, placebo-controlled study will evaluate the safety and effectiveness of Fufangdanshen Tablets in patients with vascular dementia. All patients will initially receive placebo for a 2 weeks period and then will receive Fufangdanshen Tablets or placebo for 6 months. The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 score (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and the CIBIC-plus score (Clinician's Interview Based Impression of Change - Plus Caregiver Input). Additional measures of effectiveness include the change from baseline to the end of the treatment in the MMSE score (Mini-mental State Examination), the ADL (Ability of Daily Living) score. Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 12 weeks. Effectiveness will be assessed at 12 weeks, 24weeks and 36 weeks. Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed at 12 weeks, 24weeks and 36 weeks of the study. The study hypothesis is that Fufangdanshen Tablets will be effective in the treatment of patients with vascular dementia and will be well tolerated. Double-blind: Fufangdanshen Tablets: 3 tablets per time, 3 times per day, and placebo : 3 tablets per time, 3 times per day. The placebo has similar smile and appearance as the Fufangdanshen Tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Dementia

Keywords

Vascular dementia, Fufangdanshen Tablets, Randomized Controlled trial, Chinese Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fufangdanshen Tablets

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

3 tablets per time, 3 times per day for 24 weeks. The placebo has similar smile and appearance as the Fufangdanshen Tablets

Intervention Type

Drug

Intervention Name(s)

Fufangdanshen Tablets

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for 3 tablets per time, 3 times per day for 24 weeks

Primary Outcome Measure Information:

Title

Change from baseline to end of double-blind treatment Clinician's Interview Based Impression of Change - Plus Caregiver Input; Alzheimer Disease Assessment Scale-cognitive subscale

Description

Global cognition was assessed with the CIBIC-plus, at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Time Frame

24 weeks

Title

Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive. subscale (ADAS-cog)

Description

Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change in functional scores: Activities of Daily Living (ADL).

Description

Functional ability was evaluated with the ADL was evaluated at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24).

Time Frame

24 weeks

Title

Change from baseline to the end of double-blind treatment in Mini-mental state examination (MMSE) scores

Description

Change in global cognition:Mini-mental state examination at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. Weighing between 45 to 90 kg; The diagnosis had also to be compatible with the findings from a recent (within last 12 months) magnetic resonance image (MRI) of the brain and The Hachinski Ischemia Scale (HIS) score>4. six months' mild to moderate VaD duration before inclusion. Mild-to-moderate dementia (Score of the Mini-Mental State Examination (MMSE) defined as between 11 to 26) The Hamilton Depression Scale (HAMD for 17 items) had a score of ≤ 12 have a consistent informant to accompany them on scheduled visits Ability to read, write, communicate, and understand cognitive testing instructions Exclusion Criteria: Neurodegenerative disorders such as Parkinson's disease, with AD and any other secondary types of dementia; cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor having significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease history of epilepsy, convulsions, drug abuse or alcohol abuse history of hypersensitivity to the treatment drugs; concomitant drugs with the potential to interfere with cognition; administration of other investigational drugs; females of child bearing potential without adequate contraception

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinzhou Tian, Ph.D, M.D

Organizational Affiliation

Dongzhimen Hospital, Beijing University of Chinese Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jing Shi, M.D

Organizational Affiliation

Dongzhimen Hospital, Beijing University of Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dongzhimen Hospital ,Beijing University of Chinese Medicine

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100700

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

27266867

Citation

Tian J, Shi J, Wei M, Qin R, Ni J, Zhang X, Li T, Wang Y. The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial. Trials. 2016 Jun 8;17(1):281. doi: 10.1186/s13063-016-1410-5.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia

We'll reach out to this number within 24 hrs