menopausal symptoms
Conditions
Interventions
A Combined formula Group:Jiawei Qing'e Fang +Erzhi Wan
A Jiawei Qing’e Fang Group:Jiawei Qing’e Fang+Erzhi Wan Placebo
A Erzhi Wan Group:Jiawei Qing'e Fang Placebo+Erzhi Wan
A Placebo Group:Jiawei Qing'e Fang Placebo+Erzhi Wan Placebo
B Jiawei Qing’e Fang Group:Jiawei Qing'e Fang+Erzhi Wan Placebo
B Erzhi Wan Group:Jiawei Qing'e Fang Placebo+Erzhi Wan
B Combined formula Group:Jiawei Qing'e Fang +Erzhi Wan
B Placebo Group:Jiawei Qing'e Fang Placebo+Erzhi Wan Placebo
Sponsors
Tianjin Univesity of TCM
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: Period A (perimenopausal period) 1. Female aged 40 to 60 years old in their perimenopausal period(marked by irregular cycles and menopausal symptoms); 2. The subjects meet diagnostic criteria of menopausal symptoms; 3. FSH>=10 IU/L; 4. At least 14 hot flushes per week within the past four weeks; 5. Sign the informed consent form. Period B (early postmenopausal period): 1. Female aged 40 to 60 years old in their early postmenopausal period 1 to 5 years; 2. The subjects meet diagnostic criteria of menopausal symptoms; 3. FSH>=20 IU/L; 4. At least 14 hot flushes per week within the past four weeks; 5. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Mammary hyperplasia, metropolypus, abnormal vaginal bleeding, myoma of uterus larger than 2.0*2.0cm; 2. Surgical menopause; 3. Irritable physique or hypersensitivity to the investigational drugs; 4. Patients with diseases as follows: Malignant tumor; hyperthyroidism, hypothyroidism, uncontrolled diabetes; Obesity (body mass index greater than 30); neurasthenia, psychiatric disorders, migraine headache; organic cardio-cerebral vascular diseases, hypertension, thrombotic diseases; gastrointestinal diseases affecting drug absorption; hematopoietic system diseases, autoimmune system diseases. Fungal or bacterial vaginal infections; 5. Abnormal hepatic function or abnormal renal function; 6. With history of smoking or alcohol abuse; 7. Use the same treatment of traditional Chinese medicine in the previous 4 weeks; Use Estrogen or estrogen/progesterone drugs through vaginal or percutaneous or Po in the passed 8 weeks; Take progesterone implants or a separate injection of estrogen in the passed 3 months; Take estrogen pills or progesterone injection in the previous 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menopause-specific quality-of-life (MENQOL); | — |
Secondary
| Measure | Time frame |
|---|---|
| FSH, E2, Testosterone;Hot flush frequency and severity;Serum lipids (total cholesterol, HDL and LDL chole; | — |
Countries
China
Contacts
Public ContactXiumei GAO
Outcome results
None listed