menopause syndrome
Conditions
Sponsors
Guangdong Provincal hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
41 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 41-60 years; 2. Menopause transition and post-menopause women. Menopause transition (MT): Menstrual; cycle changes more than 7 days at least 2 consecutive cycles or amenorrhea for 2-11 months; Post-menopause: Spontaneous amenorrhea more than 12 months or 6 months after bilateral Ovariectomy with or without Hysterectomy); 3. Women whose main complaint are vasomotor symptoms: Experiencing at leas 4 times moderate or sever hot flash daily and which leading to medical needs (The degree of severity of hot flash is described as following, mild: mild fever feeling without sweating; moderate: fever feeling with sweating which can be bear and don't disturb the daily life; sever: fever feeling with sweating which can't be bear); Meanwhile, the standard scores of Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) are less than 50 (standard score: 1.25times of raw total score); 4. Women whose main complaint is anxiety disorder or depressive disorder: standard score of SAS or SDS is more than 50, but less than 72 and these emotion disorder has been lasted more than 30 days without any other reason before study entry; 5. Meet the diagnosis criteria of TCM syndrome of liver stagnation and kidney deficiency or the syndrome of kidney yin deficiency; 6. 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 or Chinese medicine; 7. Be able and voluntary to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Abuse or depend on Psychotropic drugs within the last 12 months; Take Benzodiazepine every day 3 months prior to study entry; Currently being treated with antianxiety drugs, antidepressant, emotion stabilizers and so on; Receive hormone, non hormonal medication or any other treatment to relieve menopause symptoms within the last 3 months; Allergy to treatment medication; 2. Participate in the I, II period clinical trial within the last 6 months or III, IV period clinical trial within the last 3 months; 3. Undiagnosed vaginal bleeding within the last 12 months; or abnormal uterine bleeding with abnormality endometrial biopsy within the last 12 months; 4. Known or suspicious cervical cancer or cervical precancerous lesions; 5. Known or suspicious breast cancer; 6. Known or suspicious hormone independent cancer history or other cancer history; 7. Apparent suicide or hurt others tendencies considered by clinic jugement; 8. Severe psychiatric disease diagnosed by psychiatric physician according to the DSM-IV; 9. 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; 10. Alcohol or drugs abuse; excessive smoking more than 15 cigarettes per day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Greene Climacteric Scale;Chinese menopause rating scale; | — |
Countries
China
Contacts
Public ContactHongyan YANG
Outcome results
None listed