Menopausal syndrome
Conditions
Interventions
Experimental group:Gengnianshou Decoction
Control group:placebo
Sponsors
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Women aged =45 and =60 years old 2. Consistent with the diagnosis of Menopausal Syndrome 3.TCM syndrome differentiation is "disorder syndrome of yin-yang and qi-blood 4. Occurrence of hot flashes greater than or equal to 28 times each week in the past 3 weeks and with 4 or more days of moderate or severe hot flashes per week. 5. Volunteered to participate in the study and signed informed consent
Exclusion criteria
Exclusion criteria: 1. Have used hormone-containing products or drugs and the withdrawal time has not reached the washout period: 1 week or longer for prior vaginal hormonal products (rings, creams, gels) 4 weeks or longer for prior transdermal estrogen alone or estrogen/progestin products 8 weeks or longer for prior oral estrogen and/or progestin therapy 8 weeks or longer for prior intrauterine progestin therapy 3 months or longer for prior progestin implants and estrogen alone injectable drug therapy 6 months or longer for prior estrogen pellet therapy or progestin injectable drug therapy 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 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;Kupperman Scale;Generalized Anxiety Disorder;Patient Health Questionnaire-9;TCM syndrome integral scale; | — |
Countries
China
Contacts
Public ContactLinhua Zhao
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed