menopausal syndrome
Conditions
Interventions
control group:Lifestyle intervention combined with psychological counseling
treatment group:Lifestyle intervention plus psychological counseling combined with Chaihu-Shugan-San oral treatment
Sponsors
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Females aged 45–55 years; 2) Meeting the Western medical diagnostic criteria for menopausal syndrome with a modified Kupperman score =15; 3) TCM syndrome element differentiation conforms to the Liver Depression and Qi Stagnation Syndrome and the liver depression classification is level 2; 4) PHQ-9 score corresponds to mild depression; 5) No severe auditory/visual or cognitive impairment with the ability to cooperate in completing all examinations; 6) Agree to join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) Premature ovarian failure ovarian tumors and artificial menopause caused by bilateral ovarian radiation or chemotherapy after hysterectomy or oophorectomy; 3) Within the past 3 months those who have received menopausal hormone therapy antibiotic treatment or taken anti anxiety and anti depression drugs or lost weight through medication or surgery and have a history of alcohol or other drug abuse; 4) Abnormal uterine bleeding without a clear diagnosis; 5) Combined with serious primary diseases or malignant tumors of the heart liver kidney blood endocrine immune or nervous system diagnosed with mental illness or hyperthyroidism; 6) Individuals who have allergic reactions to the ingredients of Chaihu-Shugan-San; 7) Suffering from primary gastrointestinal inflammatory diseases such as Crohn's disease ulcerative colitis etc; 8)Vegetarians who supplement their daily diet with probiotics and prebiotics; 9) Other clinical trial participants who are currently participating in the evaluation of the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall efficacy index; | — |
Secondary
| Measure | Time frame |
|---|---|
| BDNF;characteristics of abundance and diversity, etc of gut microbiota;fecal metabolites (short chain fatty acids, etc.);TCM syndrome element score of Liver Depression and Qi Stagnation;PSS-14 score;GABA;PHQ-9 score;estradiol (E2);luteinizing hormone (LH);Ghrelin;5-HT;score of modified Kuperman menopause index;follicle-stimulating hormone (FSH); | — |
Countries
China
Contacts
Public ContactZheng Yan
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Outcome results
None listed