Menopausal syndrome
Conditions
Interventions
experimental group:Kunxinning granules + femton
control group:Kunxinning granule simulator + femton
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine for menopausal syndrome; (2) Traditional Chinese medicine syndrome differentiation is syndrome of kidney yin and yang deficiency; (3) Modified Kupperman scale score =16 points; (4) Voluntarily participate in this clinical trial, give informed consent and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Have used hormonal drugs (except those taking progesterone in the second half of the cycle), traditional Chinese medicine or botanical drugs (such as Kuntai capsules, Xiangshao granules, black cohosh, etc.) or psychotropic drugs (selective serotonin re-uptake) within 1 month before screening that may affect the efficacy evaluation. Inhibitors, selective serotonin and norepinephrine dual reuptake inhibitors, etc.), clonidine, gabapentin, or phytoestrogens (soy isoflavones, etc.), etc., have used long-acting GnRH agonists or other long-acting hormonal drugs within 3 months; (2) Artificial menopause (bilateral oophorectomy, hysterectomy, radiotherapy and chemotherapy to destroy ovarian function, etc.); (3) Endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps > 1 cm, etc.), uterine fibroids > 3.5 cm, abnormal uterine bleeding that has not been cured, postmenopausal B-ultrasound showing endometrium (double-layer) thickness = 0.5 cm (except those with no endometrial lesions found by diagnostic dilation and curettage or hysteroscopy), and pelvic surgery expected to be performed during the trial; (4) Known or suspected precancerous lesions (such as atypical endometrial hyperplasia/endometrial intraepithelial neoplasia, cervical intraepithelial lesions, etc.) or malignant tumors (such as endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, etc.); (5) Combined with a family history of breast cancer, or a tendency for breast malignant tumors (BI-RADS rating = 4), or diagnosed with breast malignant tumors; (6) Those who meet the conditions for cautious use of menopausal hormones: patients with meningioma, cholelithiasis, immune system diseases (systemic lupus erythematosus, rheumatoid arthritis), epilepsy, migraine, asthma, hematoporphyria, and otosclerosis; (7) Suffering from active venous or arterial thromboembolic disease in the past 6 months; (8) Combined with hypothyroidism or hyperthyroidism, hepatitis, tuberculosis, or a history of drug-induced liver injury; (9) Combined with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney, nervous system, hematopoietic system, or combined with severe mental illness, or intellectual disability; (10) Combined with hypertension but the blood pressure is still poorly controlled after standard drug treatment (systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg) and may suffer from hypertensive crisis, or hypotension is poorly controlled (systolic blood pressure =90 mmHg and/or diastolic blood pressure =60 mmHg); (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 (please refer to the normal reference value range of this center); (12) Hemoglobin<90g/L; (13) Pregnant women, lactating women, or those who want to have children within 3 months from the screening period to the withdrawal of medication, or plan to use hormonal oral contraceptives or other contraceptive methods containing sex hormone ingredients (such as Mirena, etc.) for contraception during the study; (14) Suspected or confirmed history of alcohol or drug abuse; (15) Known to be allergic to the components of the experimental drug or its excipients; (16) Participated in other interventional clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Symptom Score;Serum FSH, LH, E2;Menopausal quality of life (MENQOL) scale;Pittsburgh Sleep Quality Index (PSQI) Score; | — |
Countries
China
Contacts
Public ContactWang Xiaoyun
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed