menopause
Conditions
Interventions
treatment group :Chineses medicine
treatment group:combining therapy with traditional Chinese medicin
control group:Chinese medicine only
Sponsors
Guangdong Provincal hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
41 Years to 65 Years
Inclusion criteria
Inclusion criteria: vasomotor symptoms inclusive criteria: (1) Women aged 41-60 years; (2) No menstruation naturally in the past 12 months or 6 month after bilateral oophorectomy with or without hysterectomy; or no menstruation in the past 6 month, with Estrogen level less than 35pg/ml and follicle stimulating hormone (FSH) level more than 40IU/L; (3) For the post-menopause patients, the endometrial thicknes is less than 0.5cm; (4) The score of Self-Rating Anxiety Scale (SAS) is less than 50 (standard score, 1.25 times of total score); (5) The score of Self-Rating Depression Scale (SDS)is less than 50 (standard score,1.25 times of total score); (6) 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); (7) Body Mass Index (BMI) more than 18 and the weight less than 32 kg/m2; (8) 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. Mood disorder inclusion criteria: (1) Post-menopause or peri-menopause Women aged 41-65 years; (2) follicle stimulating hormone (FSH) level more than 15IU/L; (3) Diagnosis as depression disorder or anxiety disorder according to DSM-IV. Mood disorder symptoms happen in the 3 after menopause, or the 5 years after the last period, and can not be explained by or mood disorder disease; (4) The score of Self-Rating Anxiety Scale (SAS) is more than 50 (standard score, 1.25 times of total score); (5) 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; (6) informed consensus.
Exclusion criteria
Exclusion criteria: 1. Taken hormones therapy or non hormone therapy to manage menopausal symptoms within the last 3 months; 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 month; or abnormal uterine bleeding with abnormality endometrial biopsy within the last 12 month; 4. Patients with ovarian mixed tumor at any size; or ovarian cyst with diameter more than 2cm; or uterine myoma with diameter more than 5cm; 5. 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; 6. Serious endometriosis; 7. 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; 8. Alcohol consumption or Smoke more than 15 cigarettes a day; 9. Allergic to trial medication. Mood disorder exclusion critera: (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) Apparent suicide; (4) 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. (5) Known or suspicious cervical cancer or cervical precancerous lesions; (6) Known or suspicious breast cancer; (7) known or suspicious hormone independent cancer history or other cancer history ; (8) 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; (9) Allergic to trial medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Greene climactic scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| self-rating anxiety scale;self-rating anxiety scale;hot flash diary; | — |
Countries
Chine
Contacts
Public ContactXiaoyun Wang
Outcome results
None listed