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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2024-07-20

Brief Summary

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

Detailed Description

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Conditions

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Premature Ovarian Insufficiency Metabolomics Traditional Chinese Medicine Mechanism Clinical Syndrome

Keywords

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Premature Ovarian Insufficiency Metabolomics Traditional Chinese Medicine Mechanism Clinical Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group（Jiajian Guishen Formulation）

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.

Group Type EXPERIMENTAL

Jiajian Guishen Formulation

Intervention Type 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.

no-treatment control group

healthy people

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Jiajian Guishen Formulation

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.

Intervention Type DRUG

Eligibility Criteria

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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.

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

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Shi Yun

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR