Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics (JJGS and POI)

Shi Yun

Status and phase: Completed; Early Phase 1

Conditions: Metabolomics; Traditional Chinese Medicine; Premature Ovarian Insufficiency; Mechanism; Clinical Syndrome

Treatments: Drug: Jiajian Guishen Formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06102655

2023DZMEC-290

2023DZMEC-290-02 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

treatment group（Jiajian Guishen Formulation）

Experimental group

Description:

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.

Treatment:

Drug: Jiajian Guishen Formulation

no-treatment control group

No Intervention group

Description:

healthy people