Status:
COMPLETED
Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)
Lead Sponsor:
Sinphar Pharmaceutical Co., Ltd
Conditions:
Vascular Dementia
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
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...
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 recr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2002
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01475578
Start Date
March 1 2002
End Date
October 1 2002
Last Update
November 21 2011
Active Locations (5)
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1
Affiliated Hospital of Chengdu University of Traditional Chinese Medicines, China
Chengdu, China
2
Fujian Academy of Traditional Chinese Medicine
Fujian, China
3
Hospital (Traditional Chinese Medicine) Affiliated to Luzhou Medical College
Luzhou, China
4
Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine,
Shaanxi, China