MDSEarly Phase 1NCT05687513
Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation
A Early Phase 1 study testing Yisui granule in people with MDS, run by Dongzhimen Hospital, Beijing.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- MDS
- What is being tested?
- Yisui granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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.
Trial locations and contacts
No sites are listed yet.
Wjing contact
About this study
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.
- Conditions
- MDS
- Being tested
- Yisui granule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yisui granuleDrug
Yisui granule
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: Yisui granule |
| control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation index
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jing, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687513
- Sponsor's protocol ID
- 2022-09-01
- Status last verified
- Jan 2023
- First submitted
- 30 Oct 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation
- ClinicalTrials.gov ID
- NCT05687513
- Acronym / sponsor ID
- 2022-09-01
- Conditions
- MDS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Yisui granule |
| control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yisui granuleYisui granule | Drug | treatment group |
| Placeboplacebo | Drug | control group |
Primary outcome
Methylation index
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wjing contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Yisui granule in people with MDS, run by Dongzhimen Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wjing, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methylation index (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.