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A randomized, double-blind, placebo-controlled clinical trial of Yigongsan in improving anemia of low-risk myelodysplastic syndrome of spleen deficiency

A randomized, double-blind, placebo-controlled clinical trial of Yigongsan in improving anemia of low-risk myelodysplastic syndrome of spleen deficiency

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002690
Enrollment
Unknown
Registered
2019-10-21
Start date
2019-11-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

myelodysplastic syndrome

Interventions

Sponsors

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Clear diagnosis of spleen deficiency type low-risk MDS anemia patients and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. MDS combined with 5q-; 2. Blood transfusion dependence (WHO requires at least every 1 week to lose 1U red blood cells within 4 months); 3. Liver and kidney dysfunction (blood aspartate aminotransferase, alanine aminotransferase, creatinine concentration exceeds normal value more than 3 times online). 4. In addition to the treatment of drugs defined in this topic, other drugs need to be treated. 5. Recently participated in other drug clinical trials (within 2 weeks of Chinese medicine, 7 half-life periods of western medicine) 6. Those who could not complete the prescribed observations after being selected were not coordinated.

Design outcomes

Primary

MeasureTime frame
hemoglobin;TCM symptom scores;

Secondary

MeasureTime frame
hepcidin;inflammatory factors;iron metabolism;

Countries

China

Contacts

Public ContactZheng Qin

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)

m13162822636@163.com+86 13162822636

Outcome results

None listed

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