NCT07843030

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for early_phase_1

Timeline
6mo left

Started Sep 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Premature Ovarian Insufficiency

Keywords

premature ovarian insufficiencytraditional Chinese medicineoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Serum Follicle-Stimulating Hormone (FSH)

    Blood samples are collected before and after treatment.

    From baseline to 3 months after treatment initiation

Secondary Outcomes (14)

  • Serum Anti-Müllerian Hormone (AMH) Level

    From baseline to 3 months after treatment initiation

  • Serum Luteinizing Hormone (LH)

    From baseline to 3 months after treatment initiation

  • FSH/LH Ratio

    From baseline to 3 months after treatment initiation

  • Serum Estradiol (E2)

    From baseline to 3 months after treatment initiation

  • Traditional Chinese Medicine Syndrome Score

    before and 1 month after the treatment

  • +9 more secondary outcomes

Other Outcomes (1)

  • Pregnancy Rate

    From baseline to 3 months after treatment initiation

Study Arms (2)

JJGS treatment group

EXPERIMENTAL

JJGS is a traditional Chinese medicine formula administered to patients with POI for three menstrual cycles. Blood samples will be collected before and after treatment.

Drug: JJGS

Healthy control group

NO INTERVENTION

healthy people

Interventions

JJGSDRUG

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.

JJGS treatment group

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbiological
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Central Study Contacts

Yun Shi

CONTACT

+8613717926522zhyshiyun@126.com

Xiyu Li

CONTACT

+861921295189018165120161@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a non-randomized, parallel-group interventional study consisting of a POI treatment group and a healthy control group. Participants with POI will receive Jiajian Guishen Optimized Formula for three menstrual cycles and undergo assessments before and after treatment. Healthy controls will receive no intervention and undergo a single assessment at enrollment.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Gynecology

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)