Clinical Syndrome, Mechanism, Metabolomics, Premature Ovarian Insufficiency, Traditional Chinese Medicine
Conditions
Keywords
Premature Ovarian Insufficiency, Metabolomics, Traditional Chinese Medicine, Mechanism, Clinical Syndrome
Brief summary
1. Identify differential metabolites in POI patients. 2. Analysis of differential metabolites and their involved mechanism pathways.
Interventions
DRUGJiajian Guishen Formulation
Jiajian Guishen Formulation is a formulation of Traditional Chinese Medicine.POI patients will be treat with Jiajian Guishen Formulation for three menstrual cycles; their blood samples are collected before and after treatment.No drug will be used in control group, and their blood samples are collected when join the experiment.
Sponsors
Shi Yun
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
POI Inclusion Criteria: 1. Patients diagnosed by Western medicine with premature ovarian insufficiency; 2. Patients with Chinese medicine differentiation of kidney deficiency and liver depression; 3. 18 ≤ patients' age ≤ 39 years; 4. Patients who do not use other drugs during treatment; 5. Patients who voluntarily participate in this study, sign an informed consent form, and agree to take the corresponding treatment plan. The above five items must be met to be included in the POI patient group in this study. Healthy subjects inclusion criteria: 1. 18 ≤ Age≤ 39 years old; 2. menstrual regularity; 3. There is no abnormality in sex hormone and AMH examination; 4. Voluntarily participate in this research and sign the informed consent form; 5. Those who match the general information such as age, height, and weight of the patients included in POI.
Exclusion criteria
POI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| follicle stimulating hormone,FSH | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy of Traditional Chinese Medicine symptoms | before and1 month after the treatment | A sacle score to evalyate the symptoms, results of scores ranges from 0 to 108, higher scores mean more severe condition of POI.The main symptoms include menstrual cycle, menstrual flow reduction. Scoring criteria: ① normal menstrual cycle 0 points, 1-2 weeks ahead or behind the wrong 4 points, 2-3 weeks 8 points, more than 3 weeks 12 points; ② menstrual flow than the previous menstrual flow no change 0 points, menstrual flow reduction ≤ ⅓ 4 points, ⅓ \< menstrual flow reduction ≤ ½ 8 points, menstrual flow reduction \> ½ 12 points. Secondary symptoms included lumbar and knee pain, dizziness and tinnitus, loss of libido, increased urination, hot flashes and night sweats, and lower back and lower limb pain et. According to the degree of aggravation of symptoms, the total score was assigned as 0,2,4,8. |
| Improved Kupperman Scale Scoring | before and 1 month after the treatment | A sacle score to evalyate the symptoms, results of scores ranges from 0 to 39, higher scores mean more severe condition of POI.Referring to the domestic modified Kupperman Symptom Scoring Criteria in Chinese Obstetrics and Gynecology, edited by Cao Zeyi, to observe and rate perimenopausal symptoms before and after treatment and to quantify the degree of decline in ovarian function.Entries include hot flashes and sweating, sensory abnormalities, insomnia, anxiety and depression, dizziness, fatigue, muscle and joint pain, headache, palpitations, ankylosis of the skin, sexual discomfort, and urinary irritation, with different coefficients for each entry, and according to the aggravating degree of the symptom, they are divided into 0, 1, 2, and 3 points, and the coefficients corresponding to the scoring of the degree of each item are multiplied by a fixed score of the symptom to add up to the total score. |
| estradiol, E2 | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| luteinizing hormone, LH | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| testosterone, T | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| malondialdehyde | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| superoxide dismutase | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| anti mullerian hormone, AMH | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| ceruloplasmin | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| copper | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| metabolite level | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
| Differential metabolites and their related indexes of mechanism pathways | Differential metabolites will be tested on the 2~4th day of menstruation (amenorrhea patients before and after taking medication), related indexes of mechanism pathways will be tested after the analyses of differential metabolities | The results of differential metabolites and their related indexes of mechanism pathways cann't be predicted until the metabolomics test finish, because the test include hundreds of metabolites. Metabolomics results will be tested by using liquid chromatography coupled with mass spectrometry (LC-MS) to identify potential markers.All multivariate analyses and modeling on the normalized data were carried out using software SIMCA-P. Supervised analysis (orthogonal partial least squares discriminate analysis, OPLS-DA) was applied to distinguish metabolic difference between normal group and POI group. SPSS 22.0 (SPSS Inc) software was used for receiver operating characteristic (ROC) curve analyses and binary logistic regression analyses. Then their related indexes of mechanism pathways will be tested in blood samples. |
| Number of participants with abnormal laboratory test of blood routine examination results | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. white blood cell count (WBC), red blood cell (RBC) and platelet count/blood platelet count (PLT) are included. |
| Number of participants with abnormal Liver and kidney function (by laboratory test results) | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. creatinine(CREA), uric acid (UA), alanine amiotransferase(AST), aspartate aminotransferase (AST) and γ-glutamyl transpeptadase (GGT) are included. |
| reduced glutathione, GSH | On the 2~4th day of menstruation (amenorrhea patients before and after taking medication) | Blood samples are collected before and after treatment. |
Countries
China
Outcome results
None listed