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The sequential treatment of URSA with Kidney-Tonifying Blood-Activating and Heat-Clearing methods: A multicenter prospective cohort study and the construction of a predictive system for the risk of pregnancy loss and the advantageous population of traditional Chinese medicine.

The sequential treatment of URSA with Kidney-Tonifying Blood-Activating and Heat-Clearing methods: A multicenter prospective cohort study and the construction of a predictive system for the risk of pregnancy loss and the advantageous population of traditional Chinese medicine.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2024000597
Enrollment
Unknown
Registered
2024-10-22
Start date
2024-11-01
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

Exposure group:For the first trimester, take Formula A orally plus a daily multivitamin with folic acid, three weeks monthly. Skip Formula A during menstruation and use barrier contraception. Try to c
Non-exposure group:For the three months before pregnancy,take a multivitamin orally (containing folic acid, 1 tablet per day). Use barrier contraception and start trying to conceive after three months

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: ?In line with early URSA Western medicine diagnosis criteria ?Meet the diagnostic criteria for the syndrome of Kidney Deficiency and Blood Stasis-Heat in recurrent miscarriage ?Aged 18 to 40 years ?Voluntarily participate in this study and sign the informed consent form

Exclusion criteria

Exclusion criteria: ?Oral administration of other Chinese herbal medicines or proprietary Chinese medicines (with formulations similar to the studys compound) ?Combined with severe diseases of the digestive system endocrine diseases (hyperthyroidism hypothyroidism diabetes etc.) respiratory system diseases hematological diseases urinary system diseases nervous system diseases and mental illnesses. ?Uncontrolled hypertension(=160/100mmHg) or hypotension (systolic blood pressure < 95 mmHg) ?Abnormal liver or kidney function ?Patients who have used hormone or immunosuppressive drugs within the past 3 months prior to the study ?Participation in other clinical studies involving drugs within the past month and during the course of medication ?Insufficient exposure

Design outcomes

Primary

MeasureTime frame
Continuous pregnancy rate at 12 weeks gestation;

Secondary

MeasureTime frame
Incidence of depression/anxiety;Clinical pregnancy rate;Live birth rate;Obstetric complications;Ectopic pregnancy rate;Abortion rate;Biochemical pregnancy rate;Preterm birth rate;Effectiveness rate of traditional Chinese medicine treatment;

Countries

China

Contacts

Public ContactChenPing

The First Affiliated Hospital of Henan University of Chinese Medicine

pingping6768@126.com+86 137 8358 9566

Outcome results

None listed

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