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Effect of Kushen Gel Therapy on Genitourinary Syndrome of Menopause

Effect of Kushen Gel Therapy on Genitourinary Syndrome of Menopause

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070496
Enrollment
Unknown
Registered
2023-04-13
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Genitourinary Syndrome of Menopause (GSM)

Interventions

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. It is consistent with the diagnosis of menopausal genitourinary syndrome, which covers a series of symptoms and signs of vulva, vagina, lower urinary tract and sexual function mainly caused by low estrogen level. The main manifestations are: (1) Vulva: the size of the labia atrophy, pubic hair sparse loss, vulva skin susceptible to mechanical stimulation; (2) Vagina: vaginal mouth reduction, vaginal folds become shallow, weakened elasticity, mucous membrane congestion edema or pale, vaginal discharge reduction, vaginal dryness, vaginal itching, vaginal burning; (3) Lower urinary tract: urethral swelling, frequent urination, urgent urination, pain, increased nocturnal urination, urinary incontinence, repeated urinary tract infection; (4) Sexual function: decreased sexual desire, difficulty in orgasm, pain during intercourse, bleeding during intercourse, etc.; 2. Menopause >=2 years old, aged 50-65 years; 3. The uterus and bilateral appendages were intact without excision; 4. Previous sexual history; 5. Have autonomy and volunteer to participate in the survey.

Exclusion criteria

Exclusion criteria: 1. Allergic to any component of matrine gel; 2. Taking estrogen or other steroid drugs in the last three months; 3. Vaginal medication, vaginal irrigation, gynecological examination, etc., in the recent week; 4. Suffering from serious organic diseases, such as malignant tumors of the reproductive tract; 5. Unexplained abnormal vaginal bleeding; 6. Genital tract deformities; 7. Previous asexual life history; 8. The patient has been included in other studies, which is in conflict with this study.

Design outcomes

Primary

MeasureTime frame
Vaginal health index scale;

Secondary

MeasureTime frame
GSM symptom assessment scale;Microbial 16SrRNA sequencing;

Countries

China

Contacts

Public ContactMa Li

Shanghai Sixth People's Hospital

zhangshiyu1999@163.com+86 18930173472

Outcome results

None listed

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