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A randomized, double-blind, placebo-controlled, multicenter clinical study on the safety and efficacy of arsenic containing traditional Chinese medicine in the treatment of myelodysplastic syndrome

A randomized, double-blind, placebo-controlled, multicenter clinical study on the safety and efficacy of arsenic containing traditional Chinese medicine in the treatment of myelodysplastic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051306
Enrollment
Unknown
Registered
2021-09-18
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Myelodysplastic syndrome

Interventions

Sponsors

Xiyuan Hospital, Chinese Academy of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the MDS-RCMD western medicine diagnosis and classification criteria; 2. Those who meet the TCM standard of deficiency of both spleen and kidney and block of poison and blood stasis; 3. The patient's age is 18 to 80 years old; 4. The patients gave informed consent, voluntarily participated in taking the medicine, and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with other serious blood system diseases, such as paroxysmal nocturnal hemoglobinuria, acute hematopoietic stagnation, myeloproliferative diseases, etc.; 2. Hereditary blood system diseases (including immediate family members within three generations); 3. Pregnant, lactating women, patients with reproductive needs or allergies; 4. Severe heart, liver and kidney dysfunction: serum creatinine greater than the upper limit of normal; alanine aminotransferase, aspartase, bilirubin greater than 2 times the normal value; NYHA grade >= grade II; or patients with neurological diseases; 5. Those who have taken other traditional Chinese medicines one month before treatment, or participated in other clinical studies, may have an impact on the efficacy observation indicators.

Design outcomes

Primary

MeasureTime frame
routine blood test;Bone marrow cytology;Liver and kidney function;electrocardiogram;Abdominal ultrasound;

Countries

China

Contacts

Public ContactTang Xudong

Xiyuan Hospital, Chinese Academy of traditional Chinese Medicine

tangxudong001@163.com+86 13520016513

Outcome results

None listed

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