Perimenopausal Syndrome (Climacteric Syndrome)
Conditions
Interventions
Experimental Group:Oral administration of Gynecological Tiaojing No.4 Formula, 1 dose daily, divided into 2 warm doses, continuous treatment for 3 months
Control Group:Oral administration of Climen (Estradiol Valerate/Dienogest Tablets), taken regularly according to the instructions, continuous treatment for 3 months
Sponsors
Chongqing Jiangjin District Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the integrated traditional Chinese and western medicine diagnostic criteria for perimenopausal syndrome with heart-kidney imbalance pattern; 2.Females aged 45 to 55 years old; 3.Modified Kupperman Index (KI) score = 15 points; 4.Postmenopausal or menstrual disorder with a course of disease > 3 months; 5.No history of hormone replacement therapy in the past 6 months; 6.Good compliance, able to cooperate with the completion of 3-month treatment and 3-month follow-up; 7.Voluntarily sign the informed consent form for clinical research.
Exclusion criteria
Exclusion criteria: 1.Received hormone replacement therapy or other medications affecting efficacy evaluation in the past 6 months; 2.Complicated with severe organic diseases such as liver and kidney dysfunction, cardiovascular diseases, and malignant tumors; 3.With a history of mental illness or taking anti-anxiety/antidepressant drugs in the past 3 months; 4.Allergic to the study drugs (Gynecological Tiaojing No.4 Formula, Climen) or their components; 5.Pregnant or lactating women; 6.With contraindications to hormone therapy (such as unexplained vaginal bleeding, breast diseases, etc.); 7.Currently participating in other clinical trials; 8.Other conditions deemed unsuitable for participation in this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index (KI) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopause Quality of Life Questionnaire (MEN-QOL) Score;Pittsburgh Sleep Quality Index (PSQI) Score;Self-rating Anxiety Scale (SAS) Score;Self-rating Depression Scale (SDS) Score;Polysomnography (PSG) Related Indicators;Heart Rate Variability SDNN (HRV-SDNN);Serum Sex Hormone (E2, LH, FSH) Levels;Serum Inflammatory Factors (IL-6, TNF-a) Levels;Serum Neurotransmitter (5-HT, GABA) Levels;Liver and Renal Function Indicators (ALT, AST, Scr);Adverse Reaction Incidence; | — |
Countries
China
Contacts
Public ContactDandan Wang
Chongqing Jiangjin District Hospital of Traditional Chinese Medicine
Outcome results
None listed