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

• Status: Recruiting
• Trial end date: 2024-07-23
• Target enrollment: 0
• Participant gender: Female

Summary

1. Identify differential metabolites in POI patients.

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shi Yun

Criteria

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 exclusion criteria:

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

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

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

4. Patients with serious primary diseases and mental disorders such as cardiovascular and 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 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).