An Early Phase 1 interventional study of Jiajian Guishen Formulation in Premature Ovarian Insufficiency, Metabolomics and Traditional Chinese Medicine, sponsored by Shi Yun. Completed at 1 site in China. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Shi Yun · Early Phase 1, Interventional, and Treatment
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
This study's enrollment of 46 is close to the median of 48 across 113 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Shi Yun is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
POI Inclusion Criteria:
The above five items must be met to be included in the POI patient group in this study.
Healthy subjects inclusion criteria:
Exclusion Criteria:
POI exclusion criteria:
Those who met any of the above 5 criteria were excluded from this study. Healthy subjects were excluded as (1), (3), (4), (5).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Jiajian Guishen Formulation is a traditional Chinese medicine, it will be used in POI patients for three menstrual cycles; their blood samples are collected before and after treatment.
Drug: Jiajian Guishen Formulation
healthy people
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.
follicle stimulating hormone,FSH
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
anti mullerian hormone, AMH
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Evaluation of the efficacy of Traditional Chinese Medicine symptoms
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.
Time frame: before and1 month after the treatment
Improved Kupperman Scale Scoring
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.
Time frame: before and 1 month after the treatment
estradiol, E2
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
luteinizing hormone, LH
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
testosterone, T
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
malondialdehyde
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
superoxide dismutase
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
reduced glutathione, GSH
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
ceruloplasmin
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
copper
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
metabolite level
Blood samples are collected before and after treatment.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Differential metabolites and their related indexes of mechanism pathways
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.
Time frame: 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
Number of participants with abnormal laboratory test of blood routine examination results
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.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Number of participants with abnormal Liver and kidney function (by laboratory test results)
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.
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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