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

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	Complete list of historical versions of study NCT01761227 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	45 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	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	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