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NCT Number: NCT06102655

Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics

1. Identify differential metabolites in POI patients. 2. Analysis of differential metabolites and their involved mechanism pathways.

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Key information

Conditions

Premature Ovarian Insufficiency Adnexal Diseases Clinical Syndrome Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Mechanism Metabolomics Ovarian Diseases Primary Ovarian Insufficiency Traditional Chinese Medicine Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

POI Inclusion Criteria:

  • Patients diagnosed by Western medicine with premature ovarian insufficiency;
  • Patients with Chinese medicine differentiation of kidney deficiency and liver depression;
  • 18 ≤ patients' age ≤ 39 years;
  • Patients who do not use other drugs during treatment;
  • 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:

  • 18 ≤ Age≤ 39 years old;
  • menstrual regularity;
  • There is no abnormality in sex hormone and AMH examination;
  • Voluntarily participate in this research and sign the informed consent form;
  • Those who match the general information such as age, height, and weight of the patients included in POI.

Exclusion criteria

POI exclusion criteria:

  • Patients with congenital gonadal dysplasia or a family history similar to "early menopause";
  • POI patients with acquired organic lesions or ovarian surgery;
  • Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months;
  • Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;
  • Patients who are breastfeeding or pregnant;
  • Patients who are allergic to the drugs used in this study or have a history of previous allergy to traditional Chinese medicines.

Those who met any of the above 5 criteria were excluded from this study. Healthy subjects were excluded as (1), (3), (4), (5).

Treatment and study plan

Jiajian Guishen Formulation

Drug

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.

Primary outcomes

  1. follicle stimulating hormone,FSH

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

Secondary outcomes

  1. anti mullerian hormone, AMH

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  2. Evaluation of the efficacy of Traditional Chinese Medicine symptoms

    Time frame: 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.

  3. Improved Kupperman Scale Scoring

    Time frame: 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.

  4. estradiol, E2

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  5. luteinizing hormone, LH

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  6. testosterone, T

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  7. malondialdehyde

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  8. superoxide dismutase

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  9. reduced glutathione, GSH

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  10. ceruloplasmin

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  11. copper

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  12. metabolite level

    Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

    Blood samples are collected before and after treatment.

  13. Differential metabolites and their related indexes of mechanism pathways

    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

    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.

  14. Number of participants with abnormal laboratory test of blood routine examination results

    Time frame: 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.

  15. Number of participants with abnormal Liver and kidney function (by laboratory test results)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shi Yun

Other

Registry information

Official study title

Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency

Acronym: JJGS and POI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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