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Efficacy and Safety of Yangxue Qingnao Pills in the Treatment of Mild to Moderate Alzheimer's Disease

NCT04780399 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-02-21

No results posted yet for this study

Summary

As a traditional Chinese medicine compound, Yangxue Qingnao Pills is proven to have beneficial effects on learning and memory ability in animal models of Alzheimer's disease(AD). The purpose of the study is to evaluate the efficacy and safety of Yangxue Qingnao Pills on patients with mild to moderate AD. This phase II randomized, double-blind, parallel controlled trial include a 2 weeks run-in period, and a 48 weeks double-blind treatment period of after randomization. Participants will be randomly allocated to Yangxue Qingnao pills high dose group (7.5 g per time,2 times per day) ; and Yangxue Qingnao pills low dose group (5 g per time,2 times per day), or placebo group. The outcome measures include general cognitive function, ability of daily living, and behavioural and psychological symptoms in AD patients.

Conditions

  • Alzheimer Disease
  • Yangxue Qingnao Pills
  • Randomized

Interventions

DRUG

Yangxue Qingnao pills

72 subjects in the Yangxue Qingnao pills group take 7.5g of Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.

DRUG

Yangxue Qingnao pills

72 subjects in the Yangxue Qingnao pills group take 5g of Yangxue Qingnao pills and 2.5g placebo identified to Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.

DRUG

Placebo

72 subjects in the placebo group take 7.5g placebo identified to Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.

Sponsors & Collaborators

  • Dongzhimen Hospital, Beijing

    lead OTHER

Principal Investigators

  • Jinzhou Tian, MD,PhD · Dongzhimen Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2024-03-01
Completion
2024-12-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780399 on ClinicalTrials.gov