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

Last updated: December 4, 2024
Sponsor: Shi Yun
Overall Status: Completed

Phase

1

Condition

Perimenopause

Treatment

Jiajian Guishen Formulation

Clinical Study ID

NCT06102655
2023DZMEC-290
2023DZMEC-290-02
  • Ages 18-39
  • Female
  • Accepts Healthy Volunteers

Study Summary

  1. Identify differential metabolites in POI patients.

  2. Analysis of differential metabolites and their involved mechanism pathways.

Eligibility Criteria

Inclusion

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 liverdepression;

  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 thepatients included in POI.

Exclusion

Exclusion Criteria:

POI exclusion criteria:

  1. Patients with congenital gonadal dysplasia or a family history similar to "earlymenopause";

  2. POI patients with acquired organic lesions or ovarian surgery;

  3. Patients who have taken Western medicine artificial cycle therapy or other endocrinetherapy in the past three months;

  4. Patients with serious primary diseases and mental disorders such as cardiovascularand cerebrovascular, liver, kidney and hematopoietic system;

  5. Patients who are breastfeeding or pregnant;

  6. Patients who are allergic to the drugs used in this study or have a history ofprevious 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).

Study Design

Total Participants: 46
Treatment Group(s): 1
Primary Treatment: Jiajian Guishen Formulation
Phase: 1
Study Start date:
July 24, 2023
Estimated Completion Date:
July 20, 2024

Connect with a study center

  • Dongzhimen Hospital, Beijing University of Chinese Medicine

    Beijing,
    China

    Site Not Available

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