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
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Sponsor:
Dongzhimen Hospital, Beijing
Collaborator:
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing
Tracking Information | |||||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Vascular Dementia | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |