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A randomized controlled multi-center clinical study of Sanzi Huangshi No. 2 pills combined with thalidomide in the treatment of low-risk MDS

A randomized controlled multi-center clinical study of Sanzi Huangshi No. 2 pills combined with thalidomide in the treatment of low-risk MDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064230
Enrollment
Unknown
Registered
2022-09-30
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Myelodysplastic Syndrome

Interventions

Control group :Thalidomide
Treatment group :Sanzi Huangshi No.2 Pill Combined with Thalidomide

Sponsors

Shanghai municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years old; 2. Meet the diagnostic criteria of MDS in Western medicine; 3. The risk is classified as lower risk; 4. Serum erythropoietin (sEPO)>500IU/ml; 5. Bone marrow blasts <5%; 6. Not suitable for immunosuppressive (IST) treatment patients; 7. Stop all drugs related to the treatment of this disease for more than 2 weeks; 8. Agree to be followed up; 9. Complete follow-up and clinically relevant medical records; 10. Those who voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: The study was excluded if any of the following criteria were met: 1. Secondary MDS; 2. 5q-patients; 3. Transplant patients and peri-transplant patients; 4. The risk is classified as higher risk; 5. Applicable to IST patients (age <= 60 years old with bone marrow blast cells 5<= %, or bone marrow hypoplasia, HLA-DR15 positive, PNH clone positive, or cytotoxic T cell clone with STAT-3 mutation); 6. Patients with other hematologic or non-hematologic tumors; 7. Combined with more serious cardiovascular and cerebrovascular, liver, kidney and other organic diseases and peripheral neuropathy; 8. Pregnant or lactating women; 9. Patients with mental illness who cannot cooperate with the treatment; 10. Patients with Class A and Class B infectious diseases; 11. Active hepatitis patients; 12. Patients who are participating in other clinical trials; 13. Patients with poor compliance.

Design outcomes

Primary

MeasureTime frame
Blood routine;Blood cell production assay;Tumor-related indicators;Tumor Microenvironment Detection;Bone marrow biopsy;—

Secondary

MeasureTime frame
Arsenic concentrations in blood;Urine routine;Fecal routine;Liver function;Kidney function;electrocardiogram;—

Countries

China

Contacts

Public ContactJiahui Lu

Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

lujiahui73@163.com+86 13601759004

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026