menopausal syndrome
Conditions
Interventions
test group:Liuwei Dihuang Glycoside Tablets+Liuwei Dihuang Pill Simulator
Positive drug control group:Liuwei Dihuang Pill+Liuwei Dihuang Glycoside Tablet Simulator
placebo group:Liuwei Dihuang Glycoside Tablet Simulator+Liuwei Dihuang Pill Simulator
Sponsors
Second Affiliated Hospital of Heilongjiang University Of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Menopausal or menstrual disorder patients aged between 45 and 55 years old. 2) Those who meet the Western medical diagnostic criteria for female menopausal syndrome. 3) Those who meet the criteria for traditional Chinese medicine differentiation of kidney yin deficiency syndrome. 4) The total score of the improved Kupperman scale is = 15 points. 5) Women with amenorrhea or menstrual disorders for 3 months (or more) and FSH>10U/L. 6) In the past 7 days, the average number of hot flashes and sweats per departure was = 3 times/24 hours. 7) Volunteer to participate in the experiment and sign an informed consent form
Exclusion criteria
Exclusion criteria: 1) Individuals with hypertension and chronic anemia (Hb = 90g/L). 2) Artificial menopause (bilateral ovariectomy, hysterectomy, radiation and chemotherapy damage to ovarian function, etc.), gynecological organic lesions (maximum diameter of uterine fibroids>3cm), patients with severe breast hyperplasia, menopausal individuals with endometrial (double layer) monitoring = 0.5cm by transvaginal ultrasound, endometriosis, adenomyosis, ovarian cysts (maximum diameter>3cm), and endometrial polyps. 3) Patients with serious primary diseases or malignant tumors such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, diabetes, etc. 4) Individuals with a history of diagnosis of hyperthyroidism, hypothyroidism, and hyperlipidemia who still require medication treatment. 5) Individuals who are known to be allergic to the medicinal materials or excipients of the investigational drug. 6) Individuals with previous diagnoses of anxiety, depression, or SAS or SDS standard scores = 50. 7) Liver function indicators (AST and/or ALT) exceed the upper limit of normal values by 1.5 times. 8) Individuals with a history of hormone use or treatment within the past month. 9) Individuals who have used traditional Chinese medicine to treat female menopausal syndrome within the past month. 10) Individuals who are currently or have participated in clinical trials of other drugs within the past month. 11) Researchers believe that there are individuals who are not suitable for participating in clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 12 weeks of medication, the normalization rate of the modified Kupperman scale score;AE/ADR; | — |
Secondary
| Measure | Time frame |
|---|---|
| After 12 weeks of medication, the improved Kupperman scale showed a decrease in values, effective rate, and single symptom score;After 12 weeks of medication, the decrease and effective rate of the quantitative grading score of traditional Chinese medicine syndrome symptoms; | — |
Countries
China
Contacts
Public ContactYang Dongxia
Second Affiliated Hospital of Heilongjiang University Of Chinese Medicine
Outcome results
None listed