Clinical Trial: Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel, Comparative, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of STA-1 Capsule in Patients With This phase II clinical trial was planned to be in double-blind, double-dummy, active-controlled, parallel, comparative, multicenter design. Two hundred and 40 eligible subjects were planned to be recruited by 5 study centers. The treatment period planned in the protocol was 3 months with 5 study visits including Randomization visit (Day 0), three post-treatment visits (1 and 2 months after Randomization visit and Final visit) and 1 follow-up visit made at 6 month after Randomization visit.

After subjects recruited by this study having read and singed the ICF, they were arranged to be collected information of demographics, medical history, allergy history, medication history, and concomitant medication. Laboratory and physical examination including vital signs were performed, and Hachinski Ischemia Score (HIS), Mini-Mental Status Examination (MMSE), and Classification of Marrow-Sea deficiency were evaluated to ensure subject's eligibility to enter this study. After the subjects were confirmed eligible, they were randomly assigned to either STA-1 or Ergoloid Mesylates group. Blessed-Roth Behavior Scale (BBS) and Activities of Daily Living (ADL) Scale were measured after subjects were randomized. These subjects were then dispensed study medications for 1-month use.

The eligible subjects were requested to bring back unused study medication, if any, to study centers at 1, 2, and 3 months (Final visit) after the Randomization visit. At these visits, measurements of MMSE, BBS, ADL scales, and Classification of Marrow-Sea deficiency were collected. Information concomitant medications and AEs were also recorded. Physical and laboratory examinations were performed at Final visit. Each subject was dispensed with study medications for his/her subsequent treatment period at month-1 and -2 visits. Unused study medications were collected
Sponsor: Sinphar Pharmaceutical Co., Ltd

Current Primary Outcome:

  • Changes from Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]
    MMSE were used to evaluate subject's change in orientation, attention and calculation, immediate recall and delayed memory, and language ability before and after treatment.
  • Changes from Baseline in Blessed-Roth Behavior Scale (BBS) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]
  • Changes from Baseline in Activities of Daily Living (ADL) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes from Baseline in the symptom scales from Chinese medicine's perspective [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]

Original Secondary Outcome: Same as current

Information By: Sinphar Pharmaceutical Co., Ltd

Dates:
Date Received: November 14, 2011
Date Started: March 2002
Date Completion:
Last Updated: November 16, 2011
Last Verified: November 2011