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Clinical Trials in China / NCT07843030
Starting soon Early Phase 1

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

NCT07843030 · tracked via the Priya Life Science China tracker
Sponsor
Shi Yun
Phase
Early Phase 1
Started
2026-09-30
Last updated
2026-09-25

Condition(s) studied

Premature Ovarian Insufficiency

Investigational drug(s) / intervention(s)

JJGS

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
39 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Serum Follicle-Stimulating Hormone (FSH) — From baseline to 3 months after treatment initiation
    Blood samples are collected before and after treatment.

Trial sites (1)

FacilityCityRegionStatus
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing China

More Shi Yun trials in China

The Correlation Between Ovarian Function and Serum Biomarkers Recruiting

Other trials for the same condition

Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency Recruiting
Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency Starting soon
Application of Platelet-rich Plasma (PRP) in Reproductive Medicine Recruiting
Phase Ⅰ/Ⅱa Trial Evaluating Intravenous hUC-MSCs Injection for Safety, Tolerability and Efficacy in Patients With POI Recruiting
Finerenone for Premature Ovarian Insufficiency (POI) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07843030 on ClinicalTrials.gov ↗ ← All trials in China