Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress

Early Phase 1Not Yet RecruitingNCT07843030

Shi Yun45 enrolled

Overview

The goal of this clinical study is to evaluate the effectiveness of JiaJian GuiShen Optimized Formula (JJGS) and explore its mechanisms involving m6A modification and oxidative stress in women with premature ovarian insufficiency (POI). The main question it aims to answer is: Does JJGS improve ovarian function in women with POI after three menstrual cycles of treatment? Twenty-five women with POI will receive JJGS, and 20 healthy women will serve as controls. Changes in FSH, E2, LH, AMH, oxidative stress markers, plasma FTO levels, whole-blood RNA m6A levels, and symptom scores will be analyzed before and after treatment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premature Ovarian Insufficiency

Interventions

JJGS is a traditional Chinese medicine formulation. Patients with POI will receive the formula for three menstrual cycles, and blood samples will be collected before and after treatment. Participants in the healthy control group will receive no intervention, and their blood samples will be collected at enrollment.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria for Participants with POI: 1. Meeting the Western medicine diagnostic criteria for premature ovarian insufficiency (POI); 2. Meeting the traditional Chinese medicine diagnostic criteria for the kidney deficiency and liver stagnation syndrome; 3. Aged 18-39 years; 4. Willing and able to provide written informed consent. Participants must meet all four criteria to be included. Inclusion Criteria for Healthy Participants: 1. Aged 18-39 years; 2. Regular menstrual cycles; 3. Normal sex hormone and anti-Müllerian hormone (AMH) levels; 4. Willing to participate in the study and provide written informed consent. Exclusion Criteria: Exclusion Criteria for Participants with POI: 1. Congenital gonadal dysgenesis or a family history of premature menopause; 2. POI caused by acquired organic disease or ovarian surgery; 3. Treatment with artificial menstrual cycle therapy or other hormonal therapy within the previous three months; 4. Severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, or psychiatric disorders; 5. Known allergy to any component of the study medication. Participants meeting any of the above criteria will be excluded. Exclusion Criteria for Healthy Participants: The same as criteria 1, 3, 4, and 5 above.

Outcomes

Primary Outcomes

Serum Follicle-Stimulating Hormone (FSH)

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

Secondary Outcomes

Serum Anti-Müllerian Hormone (AMH) Level

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

Serum Luteinizing Hormone (LH)

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

FSH/LH Ratio

Change in FSH/LH ratio before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

Serum Estradiol (E2)

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

Traditional Chinese Medicine Syndrome Score

This syndrome score evaluates three primary symptoms and twelve secondary symptoms related to traditional Chinese medicine syndrome differentiation. Total scores range from 0 to 48, with higher scores indicating more severe syndrome manifestations and a worse clinical outcome.

Time frame: before and 1 month after the treatment

Modified Kupperman Menopausal Index (KMI)

The modified KMI consists of 13 menopausal symptoms, each rated on a 0-3 severity scale and weighted by symptom-specific coefficients. Total scores range from 0 to 63, with higher scores indicating more severe menopausal symptoms and a worse clinical outcome.

Time frame: before and 1 month after the treatment

Incidence of Treatment-Emergent Adverse Events

The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.

Time frame: From baseline to 3 months after treatment initiation

HO-1

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

NQO1

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

CAT

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

SOD

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

MDA

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

FTO

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

m6a

Blood samples are collected before and after treatment.

Time frame: From baseline to 3 months after treatment initiation

Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts