menopause related disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnostic Criterion According to the "Clinical guidelines.Obstetrics and Gynecology fascicle". Chinese medical Association. People's Medical Publishing House. 2009; 1. Women aged over 40years, accompany with the menstrual disorder or menopause, the vasomotor symptoms or mood disorder symptoms or urogenital atrophy symptoms appears; 2. The level of FSH is Elevated or normalthe level of estrogen can be elevated, decreased or normal; 3. Gynecological examination or pelvic ultrasound examination to exclude organic disease. Inclusive criteria: 1. Perimenopause or postmenopause women aged 41-60 years; 2. Did not use any of the following treatment for at least 3 months before entry into the study: Western medicine, Chinese medicine or health care products which is to regulate blood fat, blood sugaror blood pressure; 3. Did not use any of the following treatment for at least 3 months before entry into the study: hormone therapy, selective elective estrogen receptor modulators, aromatase inhibitors, soybean extracts, Chinese medicine,psychotropic drugs, psychological treatment or behavioral treatment. 4. Be able and voluntary to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Abuse or depend on Psychotropic drugs 12 months prior to study entry; Take Benzodiazepine every day 3 months prior to study entry; Receive hormone and non hormonal drugs or any treatment to relieve menopause symptoms; Currently being treated with anti-anxiety drugs ,antidepressant, emotion stabilizers and sedatives; 2. Joined other Phase I and II clinical trials 6 months before or Phase III or IV clinical trials 3 months before; 3. Irregular vaginal bleeding; 4. Known or suspicious cervical cancer or cervical precancerous lesions; Known or suspicious breast cancer; known or suspicious hormone independent cancer history or other cancer history; 5. Currently or lastly diagnosed other type of mood disorder by DSM-IV, which include schizophrenia, Mental derangement, dementia, Forgotten obstacles, Anorexia, bulimia, obsessive-compulsive disorder, Anxiety disorders caused by caffeine, clinical significant cognitive impairment, manic, post-traumatic stress disorder, antisocial or borderline Important personality disorders, personality disorders, clinical two-side schizophrenia, alcohol or other things abused 0, and so on; 6. Uncontrolled and/or diagnosed internal medical conditions that are likely to interfere with or influence study treatment, eg, hepatic or renal dysfunction; thrombophlebitis; thrombotic diseases;Cerebrovascular disease; Myocardial infarction, or ischemic heart disease; gallbladder disease; diabetes mellitus requiring medical treatment; Uncontrolled or untreated hypertension (defined as systolic blood pressure higher than 160 mm Hg and/or diastolic blood pressure higher than 100 mm Hg); thyroid disease; 7. Alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM constitution scale; | — |
Countries
Chine