Sichuan Jishengtang Pharmaceutical Co., Ltd.

1.) Main efficacy indicators Compare the difference between the Wujia Yizhi granules group and the placebo group in the change of the Alzheimer's Disease Rating Scale-Cognitive Part (ADAS-cog/12) score from baseline after 12 months of treatment. Compare the difference between the Wujia Yizhi granules group and the placebo group in the change of the Clinical Dementia Rating Scale (CDR-SB) from baseline after 12 months of treatment. 2) Secondary efficacy indicators Evaluate the efficacy and safety of Wujia Yizhi granules. The trial endpoints are as follows: ? Changes in the Alzheimer's Disease Rating Scale-Cognitive Part (ADAS-cog/12) score from baseline at 3, 6, and 9 months of treatment; ? Changes in the Clinical Dementia Rating Scale (CDR-SB) score from baseline at 3, 6, and 9 months of treatment; ? Changes in the Alzheimer's Disease Collaborative Research Group-Daily Living Activities Scale (ADCS-ADL) score from baseline at 3, 6, 9, and 12 months of treatment; ? Changes in Mini-Mental State Examination (MMSE) scores at 3, 6, 9, and 12 months of treatment compared with baseline; ? Changes in Neuropsychiatric Questionnaire (NPI) scores at 3, 6, 9, and 12 months of treatment compared with baseline; ? Changes in Traditional Chinese Medicine Syndrome Scale scores at 3, 6, 9, and 12 months of treatment compared with baseline;

Phase I: Explore the effectiveness and safety of different doses of Shugan Jieyu Capsule for generalized anxiety disorder (liver depression and spleen deficiency syndrome). Phase II: Further verify the effectiveness and safety of Shugan Jieyu Capsule in treating generalized anxiety disorder.