menopause syndrome -mood disorder
Conditions
Interventions
treatment group:Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines
control group:Herbal Medicines
Sponsors
Guangdong Provincal hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
41 Years to 60 Years
Inclusion criteria
Inclusion criteria: Diagnostic criterion 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; TCM syndrome diagnostic criterion Kidney deficiency and liver stagnation syndrome.According to ,2012,Chinese Medicine Publishing House of China Inclusion criterion: 1. Age 41-60 years,meet the diagnosis of diagnositic criterion; 2. FSH>15IU/L; 3. The score of Self-Rating Anxiety Scale (SAS) is more than 50 (standard score, 1.25 times of total score); 4. 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; 5. informed consensus.
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) 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;self-rating anxiety scale;self-rating anxiety scale;Chinese menopause rating scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-HT, NE, dopamine (DA), BDNF, GABA, tryptophan, tryptophan hydroxylase (TPH), serotonin ammonia acid decarboxylase 5-HTPDC, monoamine oxidase (MAO), 5-hydroxyindoleacetic acid (5-HIAA) and 5-HT gene polymorphism; | — |
Countries
Chine
Contacts
Public ContactXiaoyun Wang
Outcome results
None listed