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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
ITMCTR
Registry ID
ITMCTR2100005322
Enrollment
Unknown
Registered
2021-09-18
Start date
2022-01-01
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

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 typing standard; (2) Those who meet the criteria of deficiency of spleen and kidney and blocking of toxin and blood stasis in traditional Chinese medicine; (3) The age of the patients ranged from 18 to 80 years; (4) The patient gave informed consent, voluntarily participated in the medication, and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Combined with other serious hematological diseases, such as paroxysmal nocturnal hemoglobinuria, acute hematopoietic stagnation, bone marrow proliferative diseases, etc; (2) Hereditary blood system diseases (including immediate relatives within three generations); (3) Pregnant and lactating women, patients with reproductive needs or allergic constitution; (4) Severe heart, liver and kidney dysfunction: serum creatinine was higher than the upper limit of normal value; Alanine aminotransferase, aspartase and bilirubin were 2 times higher than the normal value; NYHA grade = class II; Or patients with neurological diseases; (5) Taking other traditional Chinese medicine or participating in other clinical studies one month before treatment may have an impact on the efficacy observation indicators.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactTang Xudong
tangxudong001@163.com13520016513

Outcome results

None listed

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