Back to resultsStudy of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
Primary Purpose
Vascular Dementia
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
STA-1
Ergoloid Mesylates tablet
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Dementia focused on measuring Vascular Dementia
Eligibility Criteria
Inclusion Criteria:
- Meeting criteria of dementia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
- Meeting criteria of vascular dementia according to National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN)
- With Mini-Mental State Examination (MMSE score) ≦17 (illiteracy); ≦20 (elementary school); ≦24 (high school or above)
- With Hachinski's ischemic score (HIS) ≧7
- With marrow-sea deficiency from Chinese medicine's perspective
- Classified mild to moderate dementia based on MMSE score
- With body weight 45 to 95 Kg
- Aged 45 to 80 years old (inclusive). Either gender is eligible. Female subjects must be postmenopausal (for at least 1 year) women without fertility
- Having signed informed consent form
- Correct understanding of pharmaceutical research and good compliance to study personnel's observation and evaluation
Exclusion Criteria:
- Dementia besides study indication based on DSM-IV and NINDS/AIREN, e.g. Alzheimer's disease, Lwey body disease, etc.
- With HIS < 7
- Diagnosed significant depression based on DSM-IV with score >8 or with other mental diseases/disorders
- With cognitive dysfunction caused by head impairment
- With medical history of epilepsy, encephalitis, or any other diseases that may result in dementia, e.g. Parkinson's disease, Huntington disease, Pick disease, etc. Patients with epilepsy attacked occasionally should be examined at the first visit by electroencephalography (EEG) and should be excluded from this study if by the test results are positive.
- With certain diseases that may interfere the evaluation of cognitive function, including abuse of alcohol, or DSM-IV diagnosed abuse of drugs or mental drugs in past 5 years. Severe anemia patients should also be excluded.
- With severe mental dysfunction, e.g. hemiplegia, aphasia, visually and hearing impairment, etc.
- With cardiac disorder, e.g. heart rate ≦ 50 or ≧ 180 times/minute
- With supine or sitting Systolic blood pressure ≦ 100 or ≧ 180 mmHg
- With other disease, especially hepatic, renal, or cardiac disorders, e.g. ALT/SGPT or AST/SGOT > 3 times of upper limit of normal range, serum creatinine > 177 umol/L (2mg/dL), or congestive heart failure (cardiac function 2-4 in classification)
- With malignant neoplasm
- With thyroid dysfunction or syphilis
- Failed to control diabetes. Diabetes patients can not enter the study unless the status becomes stable through dietary modification, taking hypoglycemic agents, or receiving insulin.
- With asthma or chronic obstructive pulmonary disease
- With multiple neuritis
- With myasthenia gravis and amyotrophic
- With severe indigestion, or gastrointestinal obstruction, or gastric and duodenal ulcer, or other gastrointestinal diseases that can affect drug absorption
- With glaucoma
- Ever attending other clinical trials in past 30 days
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STA-1
Ergoloid Mesylates
Arm Description
STA-1 capsule (Cistanche tubulosa), 2 capsules/time, 3 times/day, orally Dummy Ergoloid Mesylates tablet (Placebo), 2 tablets/time, 3 times/day, orally
Ergoloid Mesylates tablet, 2 tablets/time, 3 times/day, orally before meal Dummy STA-1 capsule (Placebo), 2 capsules/time, 3 times/day, orally
Outcomes
Primary Outcome Measures
Changes from Baseline in Mini-Mental State Examination (MMSE)
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)
Changes from Baseline in Activities of Daily Living (ADL)
Secondary Outcome Measures
Changes from Baseline in the symptom scales from Chinese medicine's perspective
Full Information
NCT ID
NCT01475578
First Posted
November 14, 2011
Last Updated
November 16, 2011
Sponsor
Sinphar Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01475578
Brief Title
Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinphar Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia
Keywords
Vascular Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STA-1
Arm Type
Experimental
Arm Description
STA-1 capsule (Cistanche tubulosa), 2 capsules/time, 3 times/day, orally
Dummy Ergoloid Mesylates tablet (Placebo), 2 tablets/time, 3 times/day, orally
Arm Title
Ergoloid Mesylates
Arm Type
Active Comparator
Arm Description
Ergoloid Mesylates tablet, 2 tablets/time, 3 times/day, orally before meal
Dummy STA-1 capsule (Placebo), 2 capsules/time, 3 times/day, orally
Intervention Type
Drug
Intervention Name(s)
STA-1
Intervention Description
STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally
Intervention Type
Drug
Intervention Name(s)
Ergoloid Mesylates tablet
Intervention Description
Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal
Primary Outcome Measure Information:
Title
Changes from Baseline in Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
Month 1, Month 2, , Month 3, , Month 6
Title
Changes from Baseline in Blessed-Roth Behavior Scale (BBS)
Time Frame
Month 1, Month 2, , Month 3, , Month 6
Title
Changes from Baseline in Activities of Daily Living (ADL)
Time Frame
Month 1, Month 2, , Month 3, , Month 6
Secondary Outcome Measure Information:
Title
Changes from Baseline in the symptom scales from Chinese medicine's perspective
Time Frame
Month 1, Month 2, , Month 3, , Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meeting criteria of dementia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
Meeting criteria of vascular dementia according to National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN)
With Mini-Mental State Examination (MMSE score) ≦17 (illiteracy); ≦20 (elementary school); ≦24 (high school or above)
With Hachinski's ischemic score (HIS) ≧7
With marrow-sea deficiency from Chinese medicine's perspective
Classified mild to moderate dementia based on MMSE score
With body weight 45 to 95 Kg
Aged 45 to 80 years old (inclusive). Either gender is eligible. Female subjects must be postmenopausal (for at least 1 year) women without fertility
Having signed informed consent form
Correct understanding of pharmaceutical research and good compliance to study personnel's observation and evaluation
Exclusion Criteria:
Dementia besides study indication based on DSM-IV and NINDS/AIREN, e.g. Alzheimer's disease, Lwey body disease, etc.
With HIS < 7
Diagnosed significant depression based on DSM-IV with score >8 or with other mental diseases/disorders
With cognitive dysfunction caused by head impairment
With medical history of epilepsy, encephalitis, or any other diseases that may result in dementia, e.g. Parkinson's disease, Huntington disease, Pick disease, etc. Patients with epilepsy attacked occasionally should be examined at the first visit by electroencephalography (EEG) and should be excluded from this study if by the test results are positive.
With certain diseases that may interfere the evaluation of cognitive function, including abuse of alcohol, or DSM-IV diagnosed abuse of drugs or mental drugs in past 5 years. Severe anemia patients should also be excluded.
With severe mental dysfunction, e.g. hemiplegia, aphasia, visually and hearing impairment, etc.
With cardiac disorder, e.g. heart rate ≦ 50 or ≧ 180 times/minute
With supine or sitting Systolic blood pressure ≦ 100 or ≧ 180 mmHg
With other disease, especially hepatic, renal, or cardiac disorders, e.g. ALT/SGPT or AST/SGOT > 3 times of upper limit of normal range, serum creatinine > 177 umol/L (2mg/dL), or congestive heart failure (cardiac function 2-4 in classification)
With malignant neoplasm
With thyroid dysfunction or syphilis
Failed to control diabetes. Diabetes patients can not enter the study unless the status becomes stable through dietary modification, taking hypoglycemic agents, or receiving insulin.
With asthma or chronic obstructive pulmonary disease
With multiple neuritis
With myasthenia gravis and amyotrophic
With severe indigestion, or gastrointestinal obstruction, or gastric and duodenal ulcer, or other gastrointestinal diseases that can affect drug absorption
With glaucoma
Ever attending other clinical trials in past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingjun Yang
Organizational Affiliation
Affiliated Hospital of Chengdu University of Traditional Chinese Medicines
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicines, China
City
Chengdu
Country
China
Facility Name
Fujian Academy of Traditional Chinese Medicine
City
Fujian
Country
China
Facility Name
Hospital (Traditional Chinese Medicine) Affiliated to Luzhou Medical College
City
Luzhou
Country
China
Facility Name
Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine,
City
Shaanxi
Country
China
Facility Name
Xi'an Traditional Chinese Medicine Hospital
City
Xi'an
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
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