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A multicenter, randomized double-blind, placebo-controlled study evaluating the efficacy and safety of Gongxuening capsules in reducing vaginal bleeding after medical abortion

A multicenter, randomized double-blind, placebo-controlled study evaluating the efficacy and safety of Gongxuening capsules in reducing vaginal bleeding after medical abortion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081323
Enrollment
Unknown
Registered
2024-02-28
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

Medical abortion

Interventions

Study group:Oral administration of Gongxuening capsules on the same day after medical abortion, 3 times a day, 2 capsules each time, for 9 consecutive days
Control group:Oral placebo capsules, 3 times a day, 2 capsules each time, taken continuously for 9 days

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 18 years old = Age = 40 years old; Patients who have an intrauterine pregnancy of = 7 weeks (49 days) and a gestational sac diameter of = 25 mm and are required to terminate the pregnancy without contraindications and undergo medical abortion; Patients who meet the criteria for medical abortion according to the Clinical Diagnosis and Treatment Guidelines and Technical Operation Standards: Family Planning Volume (2017 Revised Edition) (need to undergo examinations such as vaginal secretions, blood routine [reimbursement], coagulation function [reimbursement], liver and kidney function [reimbursement], electrocardiogram, and three-dimensional ultrasound of the uterine appendages [reimbursement]); Voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patients who have failed to use emergency contraceptive pills for contraception; Patients with accompanying mental state, cognitive dysfunction, and inability to cooperate with the treatment process; Patients with gastrointestinal dysfunction; Patients who have a need for oral contraceptives or intrauterine devices (IUDs) within 3 months after medical abortion; Other situations that the researcher determines are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Vaginal bleeding volume;

Secondary

MeasureTime frame
The incidence of incomplete abortion;Blood stasis time (days);Menstrual recovery time (days);Endometrial thickness (mm) [Note: Double layer];Uterine spiral artery hemodynamic levels: PI arterial pulse (peak systolic velocity, cm/s), VI (vascular index), VFI (vascular flow index) [note: bilateral];Serum sex hormone levels: estradiol (E2, pmol/L), pituitary prolactin (PRL, ng/ml), progesterone (P, nmol/L), luteinizing hormone (LH, IU/L), and follicle stimulating hormone (FSH, IU/L);

Countries

China

Contacts

Public ContactXiuxiu Jiang

Women's Hospital School of Medicine Zhejiang University

jiangxiuxiu0418@zju.edu.cn+86 135 8870 9941

Outcome results

None listed

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