A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03221894|
Recruitment Status : 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.
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 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|