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

ConditionPremature Ovarian Insufficiency

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexFemale

Age18-39

SponsorShi Yun

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

JJGS
Drug
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.

Treatment groups

45 Participants

are divided into 2 treatment groups

Group A: JJGS treatment groupExperimental treatment 1 intervention

Group B: Healthy control groupNo intervention 0 interventions

Trial outcomes