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Clinical study on the efficacy and safety of Bushen Culuan fang in treating anovulatory infertility caused by hyperprolactinemia

Gynecology of traditional Chinese medicine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000017
Enrollment
Unknown
Registered
2024-02-05
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Hyperprolactinemia

Interventions

Experimental group:BushenCuluan fang And Bromocriptine mesylate placebo
Control group:Bromocriptine mesylate tablets and BushenCuluan fang placebo

Sponsors

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Between 20 and 40 years old; (2) Meet the diagnostic criteria for infertility; (3) Meet the diagnostic criteria of hyperprolactinemia; (4) Meet the diagnostic criteria of TCM kidney deficiency and blood stasis syndrome; (5) Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) ovulation disorders or infertility caused by congenital physiological defects or malformations: (2) infertility caused by genetic factors; (3) Infertility caused by fallopian tube factors, or immune factors, or uterine fibroids, or myoadenosis, or endometriosis, or uterine dysplasia, confirmed by examination; (4) abnormal reproductive function of the spouse; (5) serious abnormalities of cardiovascular, liver, kidney or hematopoietic system; (6) Psychiatric diseases and other diseases that cause abnormal lactation; (7) Allergy to known investigational drug ingredients.

Design outcomes

Primary

MeasureTime frame
Ovulation rate;

Secondary

MeasureTime frame
Sex Hormone levels(FSH\ LH\ E2\P\T\PRL);Ovulatory B-ultrasound;Anti-mullerian hormone(AMH);Blood clotting (FIB, APTT, TT, PT);integral of TCM kidney deficiency and blood stasis syndrome;INHB;Early follicular stage B-ultrasound;Basal body temperature normalization rate;

Countries

China

Contacts

Public ContactMaKun

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

makun12348@sina.com13910218105

Outcome results

None listed

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