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

Phase 1

• Conditions: myelodysplastic syndrome

• Registration Number: ITMCTR1900002690
• Lead Sponsor: Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hemoglobin;TCM symptom scores;

Secondary Outcome Measures

Name	Time	Method
hepcidin;inflammatory factors;iron metabolism;