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

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ClinicalTrials.gov Identifier: NCT01761227
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • 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 [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • Change in functional scores: Activities of Daily Living (ADL). [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    Change in global cognition:Mini-mental state examination at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vascular Dementia
Intervention  ICMJE
  • Drug: Fufangdanshen Tablets
    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
  • Drug: Placebo
    Placebo for 3 tablets per time, 3 times per day for 24 weeks
Study Arms  ICMJE
  • Experimental: Fufangdanshen Tablets
    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
    Intervention: Drug: Fufangdanshen Tablets
  • Placebo Comparator: Placebo
    3 tablets per time, 3 times per day for 24 weeks. The placebo has similar smile and appearance as the Fufangdanshen Tablets
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2013)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761227
Other Study ID Numbers  ICMJE SFDA2005L01916
SFDA【2008】I919
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinzhou Tian, Dongzhimen Hospital, Beijing
Study Sponsor  ICMJE Dongzhimen Hospital, Beijing
Collaborators  ICMJE Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Investigators  ICMJE
Principal Investigator: Jinzhou Tian, Ph.D, M.D Dongzhimen Hospital,Beijing University of Chinese Medicine
Principal Investigator: Jing Shi, M.D Dongzhimen Hospital,Beijing University of Chinese Medicine
PRS Account Dongzhimen Hospital, Beijing
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP