Skip to content

Clinical Study of the Prevention and Treatment of URSA with Bushen Yangxue Prescription by Regulating Immune Balance of before Pregnancy

Clinical Study of the Prevention and Treatment of URSA with Bushen Yangxue Prescription by Regulating Immune Balance of before Pregnancy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092011
Enrollment
Unknown
Registered
2024-11-07
Start date
2023-04-13
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

unexplained recurrent spontaneous abortion

Interventions

control group:None
unexplained recurrent spontaneous abortion group:drink Bushen Yangxue Prescription

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: ? Consistent with the Western medicine diagnostic criteria referred to URSA and the TCM diagnostic criteria. ? women aged 20-40 years who get ready for pregnancy . ? All the participants provided written informed consent.

Exclusion criteria

Exclusion criteria: ? The chromosomal or genetic abnormalities ? The anatomical abnormalities of the reproductive system: abnormalities resulting from congenital dysplasia and/or posteriority uterine disease. ? The endocrine abnormalities: corpus luteum insufficiency, polycystic ovary syndrome, hyperprolactinemia, thyroid disorders, and diabetes mellitus. ? The genital tract infections: Toxoplasma, cytomegalovirus, rubella virus, herpes simplex virus, etc. ? Abnormalities of autoimmune antibodies: positive antibodies of anticardiolipin and/or antisperm, and/or antiendometrium, and/or antiovarian. ? Prethrombotic State: platelet aggregation rate and D-dimer abnormalities. ? Male Infertility: abnormal semen routine examination. ? Severe primary cardiac, hepatic, pulmonary, renal, or hematologic diseases that affect their survival, such as cancer or AIDS; clinically significant electrocardiographic abnormalities. ? Individuals who are unable to give full informed consent due to intellectual or behavioral impairments. ? Individuals who are suspected to have alcohol or drug abuse or really have. ? Other circumstances that reduce the likelihood of enrollment or complicate the enrollment, such as frequent changes in work environment, and that predispose to loss of follow-up, as judged by the investigator. ? Allergic State, such as a history of being allergic to two or more drugs or foods, or of being known to be allergic to the ingredients of the drug; ? Patients who are participating in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
the change of TCM scores;the effective pregnancy rate;Fetal status;

Secondary

MeasureTime frame
the differentiation proportion of CD4+T cell subpopulations ;the amount of NK cells;the level of Effector cytokine;

Countries

China

Contacts

Public ContactCong Chen

Jiangsu Province Hospital of Chinese Medicine

chenc@njucm.edu.cn+86 159 5201 9019

Outcome results

None listed

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