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Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01475578
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : November 21, 2011
Information provided by (Responsible Party):
Sinphar Pharmaceutical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Vascular Dementia Drug: STA-1 Drug: Ergoloid Mesylates tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : March 2002
Actual Primary Completion Date : October 2002
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: 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

Drug: STA-1
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

Primary Outcome Measures :
  1. Changes from Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]
    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.

  2. Changes from Baseline in Blessed-Roth Behavior Scale (BBS) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]
  3. Changes from Baseline in Activities of Daily Living (ADL) [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]

Secondary Outcome Measures :
  1. Changes from Baseline in the symptom scales from Chinese medicine's perspective [ Time Frame: Month 1, Month 2, , Month 3, , Month 6 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Meeting criteria of dementia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
  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:

  1. Dementia besides study indication based on DSM-IV and NINDS/AIREN, e.g. Alzheimer's disease, Lwey body disease, etc.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01475578

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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
Sponsors and Collaborators
Sinphar Pharmaceutical Co., Ltd
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Study Chair: Mingjun Yang Affiliated Hospital of Chengdu University of Traditional Chinese Medicines
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Responsible Party: Sinphar Pharmaceutical Co., Ltd Identifier: NCT01475578    
Other Study ID Numbers: 2001ZL272
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: November 2011
Keywords provided by Sinphar Pharmaceutical Co., Ltd:
Vascular Dementia
Additional relevant MeSH terms:
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Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ergoloid Mesylates
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Nootropic Agents
Dopamine Agonists
Dopamine Agents