ITMCTR2100005271
Not yet recruiting
Phase 4
Clinical and mechanistic study on treatment of perimenopausal syndrome with HongHua XiaoYao Pill
Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology0 sitesTBD
Conditionsperimenopausal syndrome
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- perimenopausal syndrome
- Sponsor
- Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Not specified
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