NCT06534723

Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney)

A 12-month Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 570 (estimated)
• Sponsor: Sichuan Jishengtang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial targeting patients with mild-to-moderate Alzheimer's dementia (TCM differentiated as syndrome of deficiency of spleen and kidney). 570 subjects were recruited and randomly assigned to the experimental and placebo groups at a ratio of 2:1.

Conditions

• Alzheimer's Dementia

Interventions

Type	Name	Description
DRUG	Wujia Yizhi granules	Drug: Wujia Yizhi granuless
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-08-20
• Primary completion: 2026-08-31
• Completion: 2026-12-01
• First posted: 2024-08-02
• Last updated: 2025-12-29

Locations

1 site across 1 country: China