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Clinical study on the treatment of obstetric antiphospholipid syndrome with Anzi Tiaochongtang combined with aspirin to regulate Breg cells

Clinical study on the treatment of obstetric antiphospholipid syndrome with Anzi Tiaochongtang combined with aspirin to regulate Breg cells

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000547
Enrollment
Unknown
Registered
2026-03-18
Start date
2024-07-24
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Obstetric antiphospholipid syndrome

Interventions

treatment group:Oral Anzi Tiaochong Tang combined with aspirin
control group:Oral aspirin

Sponsors

Shenzhen Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Those who meet the diagnostic criteria of Western and Traditional Chinese Medicine, aged 18-40, voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Those who do not meet the diagnostic criteria, have incomplete data, and affect the assessment of therapeutic efficacy; Both spouses have one or more chromosomal abnormalities; The male's semen routine is severely abnormal; Women with endocrine related diseases affecting pregnancy such as diabetes, hyperthyroidism, hypothyroidism, hyperprolactinemia, Addison syndrome, Cushing syndrome, etc. were excluded; Exclude patients with severe organ failure and cachexia who cannot tolerate normal pregnancy; Excluding immune related factors other than APS that may affect pregnancy; For example: immunodeficiency, autoimmune diseases (differentiated and undifferentiated connective tissue diseases, etc.); Exclude anatomical factors of the reproductive tract that may affect pregnancy, such as severe uterine malformations, intrauterine adhesions, uterine fibroids, endometriosis, etc; Exclude patients with hereditary or acquired thrombophilia syndrome; Individuals with a history of polycystic ovary syndrome and premature ovarian failure; The woman has a long history of heavy smoking and alcohol abuse. Pregnant or lactating patients; Patients may have poor compliance.

Design outcomes

Primary

MeasureTime frame
CD19+CD24hiCD27+regulatory B cells;CD3+CD4+T lymphocytes;CD16+CD56+natural killer (NK) cells;lupus anticoagulant(LA);Anticardiolipin antibody (ACA);ß 2 glycoprotein antibody titer(anti-ß2-GPI);D-dimer(D-D);Plasma prothrombin time(PT);Activated partial thromboplastin time(APTT);fibrinogen(FIB);CD3+CD8+T lymphocytes;

Countries

China

Contacts

Public ContactChen Yan

Shenzhen Maternity and Child Healthcare Hospital

13514821@qq.com13510592322

Outcome results

None listed

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