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NCT05687513 Clinical Trial

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

MDS Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05687513
Other study ID # 2022-09-01
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date January 2023
Est. completion date October 2024

Study information
Verified date January 2023
Source Dongzhimen Hospital, Beijing
Contact Wjing
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 76
Est. completion date October 2024
Est. primary completion date February 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Yisui granule
Yisui granule
• Placebo
placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Dongzhimen Hospital, Beijing

Outcome
Type Measure Description Time frame Safety issue
Primary Methylation index 8 weeks
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