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The efficacy and safety of HongHua XiaoYao Pill in patients with perimenopausal syndrome: a randomized controlled trial

Clinical and mechanistic study on treatment of perimenopausal syndrome with HongHua XiaoYao Pill

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050783
Enrollment
Unknown
Registered
2021-09-04
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

perimenopausal syndrome

Interventions

Sponsors

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy women aged 40-65 years; 2. Menstrual disorders persist for more than 3 months, or amenorrhea within 2 to 12 months; 3. Suffering from any of the following symptoms: vasomotor symptoms (hot flashes, sweating), somatic symptoms (insomnia, fatigue, headache, paresthesia), psychological symptoms (nervousness, depression) or genitourinary symptoms (dyspareunia) , vaginal dryness, urinary tract infection); 4. Serum follicle stimulating hormone (FSH) > 10 IU/L, or decreased estradiol (E2) 5. Have not received hormone replacement therapy or other drugs for perimenopausal symptoms in the past 2 months; 6. The uterus and bilateral appendages are intact without resection; 7. Sober and patients accept informed consent.

Exclusion criteria

Exclusion criteria: 1. Ovarian malignant tumor, premature ovarian failure, uterine fibroids >= 2cm, severe breast hyperplasia; 2. Combined with gynecological acute infectious diseases or other acute infectious diseases; 3. Severe liver and kidney dysfunction or other serious systemic diseases; 4. Participated in other clinical trials; 5. Patients who did not receive treatment as prescribed or who dropped out of the trial.

Design outcomes

Primary

MeasureTime frame
The modified Kupperman Index;

Secondary

MeasureTime frame
Hot flash scale (HFs);Menopause-Specific Quality of Life (MENQOL) Scale;Hamilton Depression(HAMD)Scale;Hamilton Anxiety Scale(HAMA) Scale;Sex hormone;Monoamine neurotransmitter;Vascular vasomotor factor;Expression of serum protein and mRNA level of phosphatidylinositol 3-active enzyme (PI3K), protein activator enzyme B(Akt), and phosphorylated protein kinase B(pAkt);

Countries

China

Contacts

Public ContactXu Xiaohu

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

hermanxu@163.com+86 13006111902

Outcome results

None listed

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