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Trial Title:
Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation
NCT ID:
NCT05687513
Condition:
MDS
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Yisui granule
Description:
Yisui granule
Arm group label:
treatment group
Intervention type:
Drug
Intervention name:
Placebo
Description:
placebo
Arm group label:
control group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
January 2023
Completion date:
October 2024
Lead sponsor:
Agency:
Dongzhimen Hospital, Beijing
Agency class:
Other
Source:
Dongzhimen Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687513
