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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05687513
Enrollment
76
Registered
2023-01-18
Start date
2023-01-31
Completion date
2024-10-31
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDS

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.

Interventions

DRUGYisui granule

Yisui granule

DRUGPlacebo

placebo

Sponsors

Dongzhimen Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Methylation index8 weeks

Contacts

Primary ContactWjing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026