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NOT YET RECRUITING
NCT07843030
EARLY_PHASE1

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

Sponsor: Shi Yun

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-09-30

Completion Date

2027-03-30

Last Updated

2026-09-25

Healthy Volunteers

Yes

Interventions

DRUG

JJGS

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.

Locations (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China