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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01475578
First received: November 14, 2011
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Vascular Dementia
Drug: STA-1
Drug: Ergoloid Mesylates tablet
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Sinphar Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 240
Study Start Date: March 2002
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475578

Locations
China
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
Investigators
Study Chair: Mingjun Yang Affiliated Hospital of Chengdu University of Traditional Chinese Medicines
  More Information

No publications provided

Responsible Party: Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01475578     History of Changes
Other Study ID Numbers: 2001ZL272
Study First Received: November 14, 2011
Last Updated: November 16, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sinphar Pharmaceutical Co., Ltd:
Vascular Dementia

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ergoloid Mesylates
Dihydroergotoxine
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Nootropic Agents
Central Nervous System Agents
Dopamine Agonists

ClinicalTrials.gov processed this record on July 22, 2014