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

Primary Purpose

MDS

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Yisui granule
Placebo
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MDS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

A. Diagnosed as myelodysplastic syndrome, IPSS score 0-1; B. It meets the syndrome standard of "deficiency of both qi and yin, internal resistance of blood stasis"; C. Newly diagnosed cases or no application of other Chinese and western medicines or treatment schemes in the past month; D. Take the test voluntarily and sign the informed consent form.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    treatment group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Methylation index

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2022
    Last Updated
    January 13, 2023
    Sponsor
    Dongzhimen Hospital, Beijing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05687513
    Brief Title
    Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation
    Official Title
    Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dongzhimen Hospital, Beijing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    MDS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Yisui granule
    Intervention Description
    Yisui granule
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    Methylation index
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    A. Diagnosed as myelodysplastic syndrome, IPSS score 0-1; B. It meets the syndrome standard of "deficiency of both qi and yin, internal resistance of blood stasis"; C. Newly diagnosed cases or no application of other Chinese and western medicines or treatment schemes in the past month; D. Take the test voluntarily and sign the informed consent form.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wjing

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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