Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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 Vascular Dementia (Marrow-Sea Deficiency)|
- Changes from Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Changes from Baseline in Activities of Daily Living (ADL) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ] [ Designated as safety issue: No ]
- Changes from Baseline in the symptom scales from Chinese medicine's perspective [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2002|
|Study Completion Date:||October 2002|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
STA-1 capsule (Cistanche tubulosa), 2 capsules/time, 3 times/day, orally
Dummy Ergoloid Mesylates tablet (Placebo), 2 tablets/time, 3 times/day, orally
STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally
Active Comparator: Ergoloid Mesylates
Ergoloid Mesylates tablet, 2 tablets/time, 3 times/day, orally before meal
Dummy STA-1 capsule (Placebo), 2 capsules/time, 3 times/day, orally
Drug: Ergoloid Mesylates tablet
Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal
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.
|Affiliated Hospital of Chengdu University of Traditional Chinese Medicines, China|
|Fujian Academy of Traditional Chinese Medicine|
|Hospital (Traditional Chinese Medicine) Affiliated to Luzhou Medical College|
|Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine,|
|Xi'an Traditional Chinese Medicine Hospital|
|Study Chair:||Mingjun Yang||Affiliated Hospital of Chengdu University of Traditional Chinese Medicines|