Menopausal syndrome
Conditions
Interventions
Treatment group:Gengnianshou Decoction
Control Group:Placebo
Sponsors
The Affiliated Hospital to Changchun University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Women aged >= 40 years and = 10 U/L; Menopausal transition period: in the early menopausal transition period, the length of menstrual cycle varies. In 10 menstrual cycles, 2 or more adjacent menstrual cycle changes >= 7 days and follicle stimulating hormone (FSH) >= 10 U/L; In the late menopausal transition period, the menstrual cycle >= 60 days, but the last menstrual period was within 1 year and FSH >= 25 U/L; Early postmenopausal period: the interval between amenorrhea is 1 to 6 years; 3. TCM syndrome differentiation is yin and yang qi and blood imbalance; 4. At least 28 hot flashes per week for 3 weeks; And moderate or severe hot flashes occurred 4 or more days a week; 5. Volunteer to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have used hormone-containing products or drugs and the withdrawal time has not reached the washout period: 1) No use of vaginal hormone products (ring, cream, gel) for less than 1 week; 2) Discontinuation of transdermal estrogen or estrogen/progesterone products for less than 4 weeks; 3) Stop oral estrogen and/or progesterone treatment for less than 8 weeks; 4) Stop intrauterine progesterone treatment for less than 8 weeks; 5) Stop progesterone implantation and monohormone injection for less than 3 months; 6) Stop progesterone granule therapy or monohormone injection drug treatment for less than 6 months; 2. Those who have used prescribed traditional Chinese medicines, sychotropic drugs (selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, monoamine oxidase inhibitors) or other antidepressants and anti-anxiety drugs that may affect the efficacy within 4 weeks; have used tamoxifen, toremifene, raloxifene or any other selective estrogen receptor modulator (SERM) or aromatase inhibitors within 8 weeks; 3. Mandatory indications for hormone use (such as active osteoporosis); 4. Those with serious primary diseases such as uterus, ovary, breast, liver, kidney, cardiovascular and hematopoietic system; 5. Patients with undiagnosed irregular vaginal bleeding who have not been cured, have uterine diseases such as endometrial polyps, uterine fibroids (diameter >= 2cm), and postmenopausal women with endometrial thickness >= 0.5cm; 6. Patients with hormone-related malignant tumors; 7.Those with other serious diseases who cannot tolerate this treatment; 8. Patients with bipolar disorder, schizophrenia and other mental diseases; 9. Patients with allergic constitution or allergies to the test drug or its components; 10. Participated in or are participating in other clinical investigators within 30 days before enrollment; 11. The researcher believes that it is not suitable to participate in this clinical research for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in daily frequency of hot flashes from baseline to week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in hot flash severity score;Mean change from baseline in hot flash diaturbing score;Hot Flash Related Daily Interference Scale;Kupperman Scale;Generalized Anxiety Disorder;Patient Health Questionnaire-9;TCM syndrome integral scale;Pittsburgh sleep quality index; | — |
Countries
China
Contacts
Public ContactLinhua Zhao
Guang’anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed