A randomized clinical trial for Erxian Decoction and Guizhi Decoction in the treatment of Perimenopausal Syndrome (PMS)
- Conditions
- Perimenopausal Syndrome
- Registration Number
- ITMCTR1900002883
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Women over 40 years old;
2. According to the diagnosis of perimenopausal syndrome, there were more than two changes in the length of the adjacent menstrual cycle > 7 days in 10 months, and FSH > 10u/L (those with menstruation were still detected within the second to third days of menstrual cycle);
3. The score of modified Kupperman index was more than 15;
4. Signed informed consent.
1. Uterine fibroids > 3cm, or adenomyosis, or endometriosis, or bilateral ovariectomy, or severe hyperplasia of the breast, or malignant tumors of the reproductive system;
2. The vagina irregular bleeding with unknown cause was not cured;
3. Patients with severe primary diseases or psychosis, such as cardiovascular, cerebrovascular, liver, kidney, endocrine and hematopoietic system;
4. Those who have used sex hormone drugs in the past 3 months;
5. Presence of conditions affecting oral drug absorption (such as gastrectomy);
6. Patients with allergic constitution;
7. Those who have used antibiotics in the past 2 weeks.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The score of modified Kupperman index;
- Secondary Outcome Measures
Name Time Method Menopause Rating Scale;Serum sex hormone level;Gut microbiota structure;