Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation

Early Phase 1

Not yet recruiting

• Conditions: MDS
• Interventions: Drug: Yisui granule; Drug: Placebo

• Registration Number: NCT05687513
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief Summary

The goal of this clinical trial is to explore the mechanism of Yisui Granule(YSG) in the treatment of myelodysplastic syndrome(MDS) through demethylation.

Under the same condition of basic western medicine treatment, the treatment group used the same traditional Chinese medicine decoction pieces as YSG, and the control group was given placebo. Through a randomized controlled clinical study, we focused on observing the effects of MDS patients on clinical symptoms (including single symptom), fatigue relief, quality of life, peripheral blood picture, blood transfusion interval and blood transfusion volume, and measured the expression of DNMTs, the expression and methylation level of Wnt3a、β-catenin、SFRP and other indicators, as well as cytokines, were used to explore the mechanism of YSG in the treatment of MDS through demethylation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-30
• Status Verified: 2023-01
• Study Start: 2023-01
• Study First Submitted QC: 2023-01-13
• Last Update Submitted: 2023-01-13
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18
• Primary Completion: 2024-02
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Yisui granule	-
control group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Methylation index	8 weeks