drugset / Trial / NCT05269173

Efficacy and Safety of Flos Gossypii Flavonoids Tablet in the Treatment of Alzheimer's Disease

NCT05269173 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

In clinical trials of preclinical pharmacodynamic studies, Flos Gossypii Flavonoids Tablet has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. Phase I clinical tolerance test is to observe the human body's tolerance to Flos Gossypii Flavonoids Tablet, and provide a basis for the formulation of safe and reasonable dosing regimens for phase II clinical trials. Therefore, a Phase II clinical trial is now being conducted to explore the efficacy and safety of the Flos Gossypii Flavonoids Tablet in the treatment of mild to moderate Alzheimer's disease (marinus sea deficiency/brain collateral stasis syndrome). In this study, the researchers will use a multicenter, randomized, double-blind, placebo-controlled parallel method to recruit AD patients to confirm the efficacy and safety of Flos Gossypii Flavonoids Tablet. Confirmation of drug efficacy will be observed through changes in AD patients' general cognitive and different cognitive domain functions, daily living activities, and symptom severities.

Timeline

Start
2020-10-29
Primary completion
2024-08-13
Completion
2024-11-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Flos gossypii flavonoids tablet Unknown 2.7 g Oral
Comparator Flos gossypii flavonoids tablet Unknown 4.5 g Oral

Indications