Skip to content

A randomized, double-blind, placebo-parallel controlled clinical trial of Zhinao Capsule in the treatment of mild and moderate Alzheimer's disease

A randomized, double-blind, placebo-parallel controlled clinical trial of Zhinao Capsule in the treatment of mild and moderate Alzheimer's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066501
Enrollment
Unknown
Registered
2022-12-07
Start date
2022-12-08
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Alzheimer's disease (AD)

Interventions

Experimental group:Zhinao capsule (0.4g/ pill, orally, 3 capsules per time, 3 times a day) + Donepezil tablets (5mg/ pill, orally, 1 tablet per time, taken before going to bed at night, the dose was m
Control group:Zhinao capsule simulator (oral, 3 capsules a time, 3 times a day) + Donepezil tablets (5mg/ tablet, orally, 1 tablet a time, before going to bed at night, the dose maintained for 4 weeks

Sponsors

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of AD Western medicine; 2. Aged between 45 and 85 years; 3. The Simple Mental State Scale (MMSE) was 10 to 26 points, indicating mild and moderate AD; 4. CDR score dementia belongs to mild and moderate patients (CDR equals 1.0 or 2.0); 5. Hachinski ischemia scale is less than or equal to 4 points; 6. Hamilton depression scale is less than or equal to 7 points; 7. Brain MRI showed reduced volume of hippocampus or atrophy of medial temporal lobe; 8. The patient or legal representative shall give informed consent and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who have no reliable care; 2. Complicated with serious primary diseases of the heart, brain, liver, kidney and hematopoietic system; 3. Mental patients; 4. Long-term use of traditional Chinese medicine for the treatment of AD affects the efficacy evaluation; 5. Allergic constitution or allergic to test drugs; 6. Patients with severe gastric and duodenal diseases affecting drug absorption; 7. Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Alzheimer's Disease Rating Scale-Cognition (ADAS-cog);Clinical Dementia Rating Scale (CDR);Alzheimer's Disease Syndrome Factor Scale (AD-PS-11);

Secondary

MeasureTime frame
Activities of Daily Living (ADL);Mini-mental State Examination (MMSE);Montreal Cognitive Assessment Scale (MoCA);

Countries

China

Contacts

Public ContactXie Wenting, Yang Wenming

The First Affiliated Hospital of Anhui University of Chinese Medicine

xiewenting1014@163.com+86 15056945439

Outcome results

None listed

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