menopause syndrome
Conditions
Interventions
treatment group(vasomotor symptoms):Chinese herbal medicine
control group(vasomotor symptoms):LIVIAL
treatment group(mood disorder):combined therapy with traditional Chinese medicine based psychotherapy and herbal medicines
control group(mood disorder): Chinese herbal medicine
Sponsors
Guangdong Provincal Hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
41 Years to 60 Years
Inclusion criteria
Inclusion criteria: I. Vasomotor symptoms Conventional medicine Diagnostic Criterion According to the "Clinical guidelines.Obstetrics and Gynecology fascicle". Chinese medical Association. People's Medical Publishing House. 2007; 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 normal, the level of estrogen can be elevated, decreased or normal; 3. Gynecological examination or pelvic ultrasound examination to exclude organic disease. II. Syndrome diagnostic criteria: According to "The Gynecology of traditional Chinese Medicine". Luosongping. Chine Medical Science press.2008; "The guidelines of characteristics and advantages of TCM clinical treatment". Luo yunjian, Sun sulun. People's Medical Publishing House. 2007. Deficiency of Kidney Yin: Main symptoms: hot flash, sweating; Minor symptoms: Dizzy and tinnitus, Soreness of waist and knee, heat of hand and foot, insomnia and dreaminess, heel pain, or skin itching, dry mouth, Dry stool, Oliguria with yellow color. Red tongue, less moss, fine and frequently pulse. To diagnose the syndrome, main symptoms and pulse and tongue are necessary,and at least the other 2 minor symptoms are included. III. Inclusive criterion 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 = 40IU/L; 3. For the post-menopause patients, the endometrial thickness 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)>=18 and <=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 I. Modern medicine Diagnostic Criterion: According to the "Clinical guidelines.Obstetrics and Gynecology fascicle". Chinese medical association. People's Medical Publishing House. 2007. 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 normal, the level of estrogen can be elevated, decreased or normal; 3. Gynecological examination or pelvic ultrasound examination to exclude organic disease; II. syndrome diagnostic criterion: According to "The Gynecology of traditional Chinese Medicine". Luosongping. Chine Medical Science press.2008; "The guidelines of characteristics and advantages of TCM clinical treatment". Luo yunjian, Sun sulun. People's Medical Publishing House. 2007. Deficiency of Kidney and Stagnation of liver Qi: Main symptoms: hot flash and sweating, mood
Exclusion criteria
Exclusion criteria: Vasomotor symptoms 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 >2cm; or uterine myoma with diameter >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 >160 mmHg and/or diastolic blood pressure >100 mmHg); thyroid disease; 8. Alcohol consumption or Smoke more than 15 cigarettes a day; 9. Allergic to trial medication. Mood disorder 1. Abused or dependent psychotropic drugs in the last 12 months, benzodiazepine medicine used each day in the last 3 months;Taken hormones therapy or non hormone therapy to manage menopausal symptoms within the last 3 months; Anxiolytics, antidepressants, mood stabilizers, or sedative used at present; 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. Suicidal tendency; 4. Other psychological disease Diagnose or diagnosed by "Diagnostic and Statistical Manual of Mental Disorders" IV, which include Schizophrenia, mental disorder, mental disorder, dementia, amnestic disorder, anorexia, bulimia, obsessive-compulsive disorder, anxiety disorder, caffeine causes clinically significant cognitive impairment, mania, anxiety disorder after trauma, clinical or borderline personality disorder, antisocial personality disorder, bipolar to schizophrenia, alcohol abuse etc.; 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 >160 mmHg and/or diastolic blood pressure >100 mmHg);thyroid disease; 9. Allergic to trial medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Greene climactic scale;Chinese menopause rating scale;hot flash diary;Self rating depression scale;Self rating anxiety scale; | — |
Countries
Chine
Contacts
Public ContactXiaoyun Wang
Outcome results
None listed