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Shenxiong Huanglian Jiedu Formula in the treatment of mild to moderate Alzheimer's disease:a randomized controlled trial

Shenxiong Huanglian Jiedu Formula in the treatment of mild to moderate Alzheimer's disease:a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000106
Enrollment
Unknown
Registered
2024-06-23
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease

Interventions

treatment group:Shenxiong Huanglian Jiedu granule

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) It conforms to the diagnostic standard of western medicine (refer to the core clinical standard of AD dementia formulated by NIA-AA in 2011) and the syndrome differentiation standard of traditional Chinese medicine; 2) Patients with mild to moderate AD: the total score of mini-mental state examination(MMSE) is 10-26; Clinical Dementia Rating(CDR) score is 1-2; 3) Age =60 years and =85 years; 4) The course of disease is =6 months; 5) The subjects can complete neuropsycholosgical test ; 6) The subjects have stable caregivers; 7) Patients and their legal guardians agree to participate in the experiment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Dementia caused by other reasons, such as vascular dementia, Lewy body dementia, frontotemporal dementia, brain tumor, hydrocephalus, alcoholism, etc. 2) Patients with serious circulatory system, respiratory system, digestive system and other diseases; 3) Severe liver and kidney dysfunction; 4) Patients tak drugs that affect cognitive function except research drugs within one month; 5) Patients are allergic or known to be allergic to the drug ingredients in the study.

Design outcomes

Primary

MeasureTime frame
Alzheimer's disease assessment scale-cog, ADAS-cog;mini-mental state examination, MMSE;

Secondary

MeasureTime frame
TNF-a;Aß1-42;T-tau;Activity of Daily Living Scale,ADL;IL-1ß;P-tau181;NfL;MDA;Clinical Dementia Rating,CDR;IL-6;TCM Syndrome Rating Scale;GSH-Px;Blood rheology;SOD;

Countries

China

Contacts

Public ContactLiHao

Wangjing Hospital, China Academy of Chinese Medical Sciences

xyhplihao1965@126.com133 1138 2093

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026