Female menopausal syndrome
Conditions
Interventions
experimental group:Nvzhen granules
control group:Kuntai Capsules
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Consistent with the diagnosis of female menopausal syndrome; 2. Syndrome differentiation of traditional Chinese medicine is liver and kidney Yin deficiency, heart and liver fire hyperactivity syndrome; 3. Participate in this clinical trial voluntarily, give informed consent and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. In the late postmenopausal period (>6 years after the final menstrual period); 2. Have used sex hormone drugs that affect ovarian function before screening and the withdrawal time has not reached the washout period: (1)1 week or longer for prior vaginal hormonal products (rings, creams, gels) ; (2)4 weeks or longer for prior transdermal estrogen alone or estrogen/progestin products; (3)8 weeks or longer for prior oral estrogen and/or progestin therapy; (4)8 weeks or longer for prior oral estrogen and/or progestin therapy; (5)3 months or longer for prior progestin implants and estrogen alone injectable drug therapy; (6)6 months or longer for prior estrogen implants or progestin injectable drug therapy. 3. Those who have used traditional Chinese medicines or botanical drugs(such as Kuntai capsules, Xiangshao granules, Lifumin, or similar drugs) ,sychotropic drugs (selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, monoamine oxidase inhibitors) that may affect the efficacy within 4 weeks; or those who have used tamoxifen, toremifene, raloxifene or any other selective estrogen receptor modulator or aromatase inhibitors within 8 weeks; 4. Artificial menopause (bilateral ovariectomy, hysterectomy, ovarian function destruction by radiotherapy and chemotherapy, etc.), severe breast hyperplasia (BI-RADS rating = 4 level), endometrial polyps>1.5 cm, and postmenopausal vaginal color ultrasound showing endometrial (double layer) thickness = 0.5 cm. Pelvic surgery is expected to be performed during the trial period; 5. Known or suspected precancerous lesions (such as endometrial atypical hyperplasia/endometrial intraepithelial neoplasia, etc.) or malignant tumors (such as breast cancer, endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, etc.) affected by sex hormones; 6. Pelvic tuberculosis or suppurative pelvic inflammatory disease; 7. Combined with mental illnesses such as anxiety, depression, or intellectual disabilities; 8. Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems; 9. Combined with hypertension, but after standardized drug treatment, blood pressure is still poorly controlled (poor control refers to systolic and diastolic blood pressure = 140mmHg and/or diastolic blood pressure = 90mmHg), and blood sugar in diabetes is poorly controlled (HbA1c = 8.5%); 10. Concomitant hyperthyroidism, hepatitis, or a history of drug-induced liver injury; 11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>1.5 times the upper limit of the normal reference value, or serum creatinine (Scr)>the upper limit of the normal reference value; 12. Pregnant women, lactating women, or those who have fertility requirements within 3 months from screening period to discontinuation of medication, or plan to use hormonal contraception methods or other contraception methods containing sexual hormones (such as mirena) during the study period for contraception; 13. Suspected or actual history of alcohol and drug abuse; 14. Known allergies to the components of the investigational drug; 15. Participated in other clinical trials within the 3 months before randomization; 16. The researcher believes that there are other circumstances that are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman score; | — |
Secondary
| Measure | Time frame |
|---|---|
| symptom scores of Chinese medicine syndrome;the efficacy of Chinese medicine syndrome;Pittsburgh Sleep Quality Scale;Menopausal Quality of Survival Scale ;Changes in the mean daily frequency of moderate to severe hot flashes and sweating compared to baseline;Changes in average severity of moderate to severe hot flashes and sweating compared to baseline;Changes in daily scores of moderate to severe hot flashes and sweating compared to baseline; | — |
Countries
China
Contacts
Public ContactXiuxiang Teng
Beijing Hospital of Traditional Chinese Medicine
Outcome results
None listed