Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
NCT ID: NCT01475578
Last Updated: 2011-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2002-03-31
2002-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
STA-1
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
STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally
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
Ergoloid Mesylates tablet
Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
STA-1
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
Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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)
3. With Mini-Mental State Examination (MMSE score) ≦17 (illiteracy); ≦20 (elementary school); ≦24 (high school or above)
4. With Hachinski's ischemic score (HIS) ≧7
5. With marrow-sea deficiency from Chinese medicine's perspective
6. Classified mild to moderate dementia based on MMSE score
7. With body weight 45 to 95 Kg
8. Aged 45 to 80 years old (inclusive). Either gender is eligible. Female subjects must be postmenopausal (for at least 1 year) women without fertility
9. Having signed informed consent form
10. Correct understanding of pharmaceutical research and good compliance to study personnel's observation and evaluation
Exclusion Criteria
2. With HIS \< 7
3. Diagnosed significant depression based on DSM-IV with score \>8 or with other mental diseases/disorders
4. With cognitive dysfunction caused by head impairment
5. 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.
6. 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.
7. With severe mental dysfunction, e.g. hemiplegia, aphasia, visually and hearing impairment, etc.
8. With cardiac disorder, e.g. heart rate ≦ 50 or ≧ 180 times/minute
9. With supine or sitting Systolic blood pressure ≦ 100 or ≧ 180 mmHg
10. 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)
11. With malignant neoplasm
12. With thyroid dysfunction or syphilis
13. 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.
14. With asthma or chronic obstructive pulmonary disease
15. With multiple neuritis
16. With myasthenia gravis and amyotrophic
17. With severe indigestion, or gastrointestinal obstruction, or gastric and duodenal ulcer, or other gastrointestinal diseases that can affect drug absorption
18. With glaucoma
19. Ever attending other clinical trials in past 30 days
45 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sinphar Pharmaceutical Co., Ltd
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mingjun Yang
Role: STUDY_CHAIR
Affiliated Hospital of Chengdu University of Traditional Chinese Medicines
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Affiliated Hospital of Chengdu University of Traditional Chinese Medicines, China
Chengdu, , China
Fujian Academy of Traditional Chinese Medicine
Fujian, , China
Hospital (Traditional Chinese Medicine) Affiliated to Luzhou Medical College
Luzhou, , China
Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine,
Shaanxi, , China
Xi'an Traditional Chinese Medicine Hospital
Xi'an, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2001ZL272
Identifier Type: -
Identifier Source: org_study_id