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The study will be a 36-week multicentre, double-blind, placebo-controlled phase â…¡b trial in China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi Gan group (84mg per day) or to placebo group. The primary endpoint will be Vascular Dementia Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of Boxes. Secondary outcomes included changes in Mini-Mental State Examination, Clock Drawing Test, Delayed Story Recall and Ability of Daily Living. Patients' safety will be assessed by recording of adverse events, clinical examinations, electrocardiography and laboratory tests. The patients, caregivers, and investigators will be blinded to the treatment allocations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tian Ma Bian Chun Zhi Gan group | Experimental | Tian Ma Bian Chun Zhi Gan tablets |
|
| Placebo group | Placebo Comparator | placebo identified to Tian Ma Bian Chun Zhi Gan tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tian Ma Bian Chun Zhi Gan Tablets | Drug | Tian Ma Bian Chun Zhi Gan Tablets, 0.1g per pill which contains 14mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog) | Change from baseline to end of double-blind treatment of VADAS-Cog. VADAS-cog is a revision of the ADAS-cog to be a better measure in vascular conditions, and a higher score indicates higher impairment. In addition to ADAS-cog, the VADAS-cog comprises additional frontal lobe tests reflecting attention, working memory, executive function, and verbal fluency. | Baseline, 12-week, 24-week and 36-week. |
| Clinical Dementia Rating-Sum of Boxes (CDR-SB) | Change from baseline to end of double-blind treatment of CDR-SB.The CDR-SB is a standard for disease grading in clinical studies of dementia and is used for overall endpoint assessment in clinical trials. It comprehensively assesses the cognitive and functional aspects of dementia patients, including memory, orientation, judgment and problem-solving skills, social affairs, family and hobbies, and personal cooking. The CDR-SB scores from 0 to 18 points, and a higher score indicates higher impairment. | Baseline, 12-week, 24-week and 36-week. |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination (MMSE) | Change from baseline to end of double-blind treatment of MMSE. MMSE was used to evaluate global cognition, The maximum score for the MMSE is 30, lower score means severe impairment. | Baseline, 12-week, 24-week and 36-week. |
| Clock drawing test (CDT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinzhou Tian | Contact | +861084013380 | jztian@hotmail.com | |
| Jing Shi | Contact | +861084011920 | shijing87@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinzhou Tian | Dongzhimen Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| dongzhimmen Hospital, Beijing University of Chinese medicine | Recruiting | Beijing | Beijing Municipality | 100700 | China |
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| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Drug | Placebo identified to Tian Ma Bian Chun Zhi Gan, 0.1g per pill which contains 0mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks. |
|
The changes of the CDT from baseline after 36 weeks treatment. Executive function is assessed by CDT, the maximum score of CDT is 4 points. |
| Baseline, 12-week, 24-week and 36-week. |
| Activities of daily living (ADL) | Change from baseline to end of double-blind treatment of ADL. ADL scale is used to measure the physical self-maintenance ability and instrumental activities of daily living ability. | Baseline, 12-week, 24-week and 36-week. |
| Delayed story recall (DSR) | Change from baseline to end of double-blind treatment of DSR. DSR is used to eveluate the memory function, which scores range from 0 to 56. | Baseline, 12-week, 24-week and 36-week. |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |