The efficacy and safety of HongHua XiaoYao Pill in patients with perimenopausal syndrome: a randomized controlled trial
- Conditions
- perimenopausal syndrome
- Registration Number
- ITMCTR2100005271
- Lead Sponsor
- Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Healthy women aged 40-65;
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The modified Kupperman Index;
- Secondary Outcome Measures
Name Time Method Vascular vasomotor factor;Hamilton Anxiety Scale(HAMA) Scale;Sex hormone;Monoamine neurotransmitter;Menopause-Specific Quality of Life (MENQOL) Scale;Hamilton Depression(HAMD)Scale;Expression of serum protein and mRNA level of phosphatidylinositol 3-active enzyme (PI3K), protein activator enzyme B(Akt), and phosphorylated protein kinase B(pAkt);Hot flash scale (HFs);