Efficacy & Safety of Flos Gossypii Flavonoids Tablet in the Treatment of

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Cotton flower is a Xinjiang Uygur ethnic medicine, and its main active ingredients are flavonoids. Studies have proved that flavonoids have strong characteristics of antioxidant stress and anti-inflammatory response. Preclinical pharmacodynamic studies on rats showed that the Flos Gossypii Flavonoids Tablet could significantly improve the learning and memory ability of AD model caused by different factors, and the mechanism may be related to its inhibition of oxidative stress and inflammatory response. A total of 57 subjects were enrolled in the Phase I tolerance clinical study. The results showed that the experimental drug may temporarily increase the three indexes of glutamic oxaloacetic transaminase, creatine kinase and lactate dehydrogenase, which can self-recovery in a short time. Combined with the safety evaluation results of phase I clinical trial, Flos Gossypii Flavonoids Tablet is a drug with high safety. ;

Study Design

Related Conditions & MeSH terms

Alzheimer Disease

Clinical Trial Details

NCT number	NCT05269173
Study type	Interventional
Source	Capital Medical University
Contact	Jianping Jia, MD,PhD
Phone	0086-10
Email	jjp@ccmu.edu.cn
Status	Recruiting
Phase	Phase 2
Start date	October 29, 2020
Completion date	December 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04044495` - Sleep, Rhythms and Risk of Alzheimer's Disease	N/A
Completed	`NCT04079803` - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients	Phase 2
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT04520698` - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease	N/A
Active, not recruiting	`NCT04606420` - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease	N/A
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Terminated	`NCT03672474` - REGEnLIFE RGn530 - Feasibility Pilot	N/A
Completed	`NCT03430648` - Is Tau Protein Linked to Mobility Function?
Recruiting	`NCT05288842` - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting	`NCT04949750` - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease	N/A
Recruiting	`NCT05557409` - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation	Phase 3
Recruiting	`NCT04522739` - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease	Phase 4
Completed	`NCT06194552` - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07	Phase 1
Completed	`NCT03239561` - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants	Early Phase 1
Completed	`NCT03184467` - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients	Phase 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated	`NCT03487380` - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Recruiting	`NCT05328115` - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease	Phase 1
Completed	`NCT05562583` - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms