A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT03221894|
Recruitment Status : Unknown
Verified July 2017 by Jinzhou Tian, Dongzhimen Hospital, Beijing.
Recruitment status was: Recruiting
First Posted : July 19, 2017
Last Update Posted : July 25, 2017
|Condition or disease||Intervention/treatment|
|Alzheimer Disease||Dietary Supplement: GRAPE granules|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease|
|Actual Study Start Date :||July 15, 2017|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Conventional therapy with herbs
Patients were treated with conventional therapy with Chinese herbal medicine (GRAPE granules).
Dietary Supplement: GRAPE granules
GRAPE granules was mainly consisted of herbal medicines: Ren Shen (Ginseng, 10g/d), Di Huang (Rehmannia glutinosa, 30g/d), Shi Cangpu (Acorus tatarinowii, 10g/d), Yuan Zhi (Polygala tenuifolia, 10g/d), Yin Yanghuo (Epimedium brevicornu, 10g/d), Shan Zhuyu (Cornus officinalis, 10g/d), Rou Congrong (Cistanche deserticola, 10g/d), Yu Jin (Curcuma aromatica, 10g/d), Dan Shen (Salvia miltiorrhiza, 10g/d), Tian Ma (Angelica sinensis, 10g/d), Tian ma (Gastrodia elata, 10g/d), and Huang Lian (Berberine, 10g/d), which were supplied by Beijing Tcmages Pharmaceutical Co., LTD, Each bag of granules with 150ml warm water melt was taken orally twice a day.
Conventional therapy alone
In conventional therapy group, donepezil was the commonly used ChEI(cholinesterase inhibitor) to treat mild to severe AD patients. Memantine, a NMDA(N-methyl-D-aspartate ) antagonist, was given to moderate and severe AD patients. The dose of donepezil ranged from 5 to 10 mg once a day according to patients.
- Mini-Mental State Examination (MMSE) [ Time Frame: Up to 12 months, repeated measurement every 3 months. ]Change of global cognition was measured by MMSE, a 30-point scale, higher score indicates better cognition.
- Activities of Daily Living (ADLs) [ Time Frame: Up to 12 months, repeated measurement every 3 months. ]Both basic ADLs (6-items) and instrumental ADLs (8-items) were measured. The ADLs contain 14 items (score 1-4), the range is 14 to 56, and higher scores indicate worse function.
- Clinical Dementia Rating (CDR) [ Time Frame: Up to 12 months, repeated measurement every 3 months. ]The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. 0 = Normal, 0.5 = Very Mild Dementia, 1 = Mild Dementia, 2 = Moderate Dementia, 3 = Severe Dementia.
- Neuropsychiatric Inventory (NPI) [ Time Frame: Up to 12 months, repeated measurement every 3 months. ]NPI was used for rating the behavioral and psychological symptoms of dementia (BPSD), including 12-items, with a score rang from 0-144, higher score indicates worse state.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221894
|Contact: Jinzhou TIAN, Dremail@example.com|
|Contact: Jingnian NI, Drfirstname.lastname@example.org|
|Contact: Jing Shi, M.D. 86-10-84013132 email@example.com|
|Principal Investigator:||Jinzhou TIAN, Dr||Dongzhimen Hospital, BUCM|