Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on
      clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study
      structure planned in this project, the dosage and study structure of phase III study can be
      confirmed.
    

Detailed description: 
      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 with drug accountability documented. Subjects were dismissed from
      the study at the Final visit.

      Subjects were measured MMSE, BBS, and ADL scales at 6 months after the Randomization visit if
      they were available for follow-up evaluations.
    

Intervention name(s): STA-1; Ergoloid Mesylates tablet
Intervention type(s): Drug; Drug
Intervention description(s): STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally; Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal
Intervention MeSH terms: Ergoloid Mesylates; Dihydroergotoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vascular Dementia