Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease
NCT ID: NCT05538507
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2022-06-01
2024-06-30
Brief Summary
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Detailed Description
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The advantage of Chinese medicine is multi-target and multi-factor regulation, which has advantages in treating complex diseases. The combination of ancient smart soup with donepezil was able to significantly improve the cognitive function in demented animals. Smart Soup is prepared from three herbs: Rhizoma Acori Tatarinowii, Poria cum Radix Pini, Radix Polygalae. These three herbs are each 15 grams and ground into a very fine powder. This approach reduced the formation of characteristic pathological changes at the pathological level, therefore, the combination of ancient Chinese medicine formulae with modern medical treatment may bring new hope to the treatment of demented patients.
The main design of this study are following: Patients over 40 years of age and eligible for NIA-AA 2011 probable AD and probable MCI were included in this study and were divided into 6 groups of 30 patients each. Group I AD patients were given donepezil 10 mg, memantine 20 mg and smart soup, group II AD patients were given donepezil 10 mg, memantine 20 mg and placebo; group III AD patients were given donepezil 10 mg and smart soup, group IV AD patients were given donepezil 10 mg and placebo; group V mild cognitive impairment (MCI) patients were given smart soup, and group VI MCI patients were given placebo.
Evaluations were set before enrollment, every three months till one year and the evaluators were single-blind. The scales involved in the evaluation of cognitive function and quality of life, sleep condition, and emotional behavior included ADAS-cog, MMSE, CDR, ADL, CMAI, NPI, and EQ-5D, which were evaluated five times. MRI, EEG, blood oxidative stress indicators, and biological markers were collected at the same time at enrollment and at the end of the study. Genotype collection was completed at enrollment. Safety was also evaluated with monthly testing of ECG, routine blood, liver and kidney function, urinary routine, and recording of side effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group I severe AD
Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and smart soup
smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
Donepezil
Severe AD and mild or moderate AD will be given donepezil
Memantine
Severe AD will be given memantine
Group II severe AD
Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and placebo
Donepezil
Severe AD and mild or moderate AD will be given donepezil
Memantine
Severe AD will be given memantine
Placebo
patients with MCI will be given placebo
Group III Mild or moderate AD
Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and smart soup
smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
Donepezil
Severe AD and mild or moderate AD will be given donepezil
Group IV Mild or moderate AD
Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and placebo
Donepezil
Severe AD and mild or moderate AD will be given donepezil
Placebo
patients with MCI will be given placebo
Group V MCI
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup
smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
Group VI MCI
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo
Placebo
patients with MCI will be given placebo
Interventions
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smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
Donepezil
Severe AD and mild or moderate AD will be given donepezil
Memantine
Severe AD will be given memantine
Placebo
patients with MCI will be given placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NIA-AA 2011 AD probable Alzheimer's disease, severe, stable use donepezil 10mg/d and memantine 20mg/d for 3 months
* NIA-AA 2011 MCI probable criteria
* stable care giver
* Traditional Chinese medicine diagnosis: pixu tanzhuo
Exclusion Criteria
* contradictions of MRI examination
40 Years
90 Years
ALL
No
Sponsors
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Tongji University
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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gaojing
Professor, Department of Neurology
Principal Investigators
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Jing Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Hou Y, Wang Y, Zhao J, Li X, Cui J, Ding J, Wang Y, Zeng X, Ling Y, Shen X, Chen S, Huang C, Pei G. Smart Soup, a traditional Chinese medicine formula, ameliorates amyloid pathology and related cognitive deficits. PLoS One. 2014 Nov 11;9(11):e111215. doi: 10.1371/journal.pone.0111215. eCollection 2014.
Wang Y, Wang Y, Sui Y, Yu H, Shen X, Chen S, Pei G, Zhao J, Ding J. The combination of aricept with a traditional Chinese medicine formula, smart soup, may be a novel way to treat Alzheimer's disease. J Alzheimers Dis. 2015;45(4):1185-95. doi: 10.3233/JAD-143183.
Ling Y, Li Z, Chen M, Sun Z, Fan M, Huang C. Analysis of multiple constituents in Cong-Ming-Tang, a Chinese herbal formula for the treatment of amnesia, by high-performance liquid chromatography with quadrupole time-of-flight mass spectrometry. Phytochem Anal. 2013 Nov-Dec;24(6):677-88. doi: 10.1002/pca.2454. Epub 2013 Jul 9.
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
Other Identifiers
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Smart Soup
Identifier Type: -
Identifier Source: org_study_id
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