female menopausal syndrome
Conditions
Interventions
The high-dose Tiangui Congying Granules group:Take with boiling water, 2 bags each time (Tiangui Congying Granules), twice a day (once in the morning and once in the evening)
The low-dose Tiangui Congying granules group:Take with boiling water. 2 bags each time (1 bag of Tiangui Congying Granules + 1 bag of Tiangui Congying Granules placebo), twice a day (once in the morni
The placebo group:Take with boiling water. 2 bags each time, twice a day (once in the morning and once in the evening).
Sponsors
Guang'anmen Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. According to the "International Guidelines for Clinical Practice of Traditional Chinese Medicine - Menopausal Syndrome 2020", subjects who meet the Western medical diagnostic criteria for female menopausal syndrome and are in the perimenopausal period (the transition period of menopause and within one year after menopause) (the definition of perimenopausal period is referred to in the "Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Menopausal Syndrome (2023 Edition)"); 2. Female patients aged 45 to 55 years old with follicle-stimulating hormone (FSH) > 10 U/ L; 3. It conforms to the TCM syndrome differentiation criteria for kidney deficiency and liver depression syndrome in menopausal syndrome as stipulated in "Gynecology of Traditional Chinese Medicine"; 4. The modified Kupperman score is =16 points; 5. Those who have received drug treatment meet the following elution period requirements 1)If the subject has been treated with similar traditional Chinese medicine before, it is recommended that the elution period be no less than 4 weeks. 2)If the subjects have used estrogen alone or combined therapy with estrogen/progesterone, the recommended elution period is as follows: 1) For those who have used hormone-based preparations (rings, creams or gels) vaginally before the trial, the elution period should be no less than 5 half-lives or 1 week (whichever is longer). For those who have used estrogen or estrogen/progesterone preparations before the test, the elution period should be no less than 4 weeks. 3) For those who had been treated with oral estrogen and/or progesterone (except for short-term oral progesterone for the purpose of inducing withdrawal bleeding) before the trial, the elution period shall be no less than 8 weeks; For those who had received progesterone treatment in the uterine cavity before the test, the elution period should be no less than 8 weeks. For those who had used progesterone implantation and estrogen injections alone before the test, the elution period should be no less than 3 months. For those who have used estrogen implantation or progesterone injection before the test, the elution period shall not be less than 6 months. 6. Those who voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Poorly controlled hypertension (after drug treatment, systolic blood pressure =140mmHg and/or diastolic blood pressure =90mmHg), poorly controlled diabetes (after drug treatment, fasting venous blood glucose =8.0mmol/L) or pheochromocytoma; 2.Anemic individuals (Hb=90 g/L); 3.Artificial menopause (such as bilateral oophorectomy, hysterectomy, ovarian function damage caused by radiotherapy and chemotherapy, etc.); 4.Those with uterine fibroids larger than 3 cm or endometrial polyps larger than 1 cm; 5.Those with breast nodules (BI-RADS rating > Class 3) or severe breast hyperplasia; 6.Postmenopausal individuals with vaginal color B-ultrasound monitoring of endometrium (double-layer) =0.5 cm; 7.Subjects with unexplained vaginal bleeding or vaginal infection or urinary tract infection under medication treatment; 8.Those who are allergic to one or more drug components related to the investigational drug; 9.Those with a history of severe heart, lung or hematopoietic system diseases, and who, as determined by the researchers, may confuse the research results or affect the safety of the subjects; Those with liver function ALT and/or AST=1.5×ULN, or renal function Scr=ULN, or suffering from any other uncontrollable diseas; 10.Subjects with malignant tumors; 11.Those with unstably controlled hypothyroidism or hyperthyroidism, or thyroid nodules (C-TIRADS > Class 3); 12.Those with severe neurological or mental disorders that affect the evaluation of the efficacy and safety of the investigational drugs; 13.Those with severe mental disorders such as anxiety and depression (evaluated according to the attached "Self-Rating Anxiety Scale" and "Self-Rating Depression Scale", with a score of =60 in either the SAS or SDS standard score (i.e., moderate and severe subjects are excluded); 14.Screen out those who have smoked more than 5 cigarettes per day in the past 3 months, or consumed more than 14 units of alcohol each time (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine), or have a history of drug abuse (long-term use of non-steroidal anti-inflammatory drugs, opioids, sedatives; or frequent use of sedatives, sleeping pills or other addictive drugs); 15.Pregnant women; 16.Those who have participated in or are currently participating in other clinical trials within one month before enrollment; 17.Researchers believe that other situations where participation in clinical trials are not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improve the modified Kupperman scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Evaluation Scale;Evaluation of the therapeutic effect of individual Traditional Chinese Medicine symptoms;Perimenopausal Quality of Life Scale;Athens Insomnia Scale;Self-rating Anxiety Scale;Self-rating Depression Scale; | — |
Countries
China
Contacts
Public ContactRuihua Zhao
Guang'anmen Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed