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A randomized controlled trial for evaluation of the efficacy and safety of Ruibaishan in the treatment of intrauterine adhesions

A randomized controlled trial for evaluation of the efficacy and safety of Ruibaishan in the treatment of intrauterine adhesions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023330
Enrollment
Unknown
Registered
2019-05-22
Start date
2019-06-23
Completion date
Unknown
Last updated
2019-05-27

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

Conditions

intrauterine adhesion

Interventions

Ruibaishan group:Hysteroscopic adhesiolysis
Cook balloon implantation in uterine cavity
SIS implantation in uterine cavity
control group:Hysteroscopic adhesiolysis

Sponsors

the Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) aged 20-50 years women at childbearing age; 2) Patients with moderate or severe intrauterine adhesions were diagnosed by hysteroscopy according to the American Fertility Association score (AFS score > 5); 3) patients who can communicate well with researchers; 4) Informed consent, voluntary signature of the 'informed consent of the subject'.

Exclusion criteria

Exclusion criteria: 1) known to be taboo, intolerant or allergic to pig derived materials; 2) Severe heart, brain and kidney diseases or systemic failure affect the treatment; 3) Patients with mental illness or serious mental illness; 4) Patients with malignant tumors of female genital organs; 5) Menopause and lactation; 6) Patients who underwent uterine adhesions separation more than three times; 7) Patients who have been in clinical trials for one month or are in the process of participating in other clinical trials; 8) Researchers believe that other patients are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
AFS score;

Secondary

MeasureTime frame
Menstrual volume;endometrial thickness;Blood routine;pregnancy;

Countries

China

Contacts

Public ContactXianghua Huang

The Second Hospital of Hebei Medical University

huangxh2003@163.com+86 15803210557

Outcome results

None listed

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