Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress (JJGS ; POI)

September 21, 2026 updated by: Shi Yun

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Dongzhimen Hospital, Beijing University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JJGS treatment group

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

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.
No Intervention: Healthy control group

healthy people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Follicle-Stimulating Hormone (FSH)
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Anti-Müllerian Hormone (AMH) Level
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
FSH/LH Ratio
Time Frame: From baseline to 3 months after treatment initiation

Change in FSH/LH ratio before and after treatment.
From baseline to 3 months after treatment initiation
Serum Estradiol (E2)
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
Traditional Chinese Medicine Syndrome Score
Time Frame: before and 1 month after the treatment

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.
before and 1 month after the treatment
Modified Kupperman Menopausal Index (KMI)
Time Frame: before and 1 month after the treatment

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.
before and 1 month after the treatment
Incidence of Treatment-Emergent Adverse Events
Time Frame: From baseline to 3 months after treatment initiation

The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.
From baseline to 3 months after treatment initiation
HO-1
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
NQO1
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
CAT
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
SOD
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
MDA
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
FTO
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation
m6a
Time Frame: From baseline to 3 months after treatment initiation

Blood samples are collected before and after treatment.
From baseline to 3 months after treatment initiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: From baseline to 3 months after treatment initiation

The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.
From baseline to 3 months after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shi Yun

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

September 21, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 25, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025DZMEC-450-03
  • 2025DZMEC-450-03 (Other Identifier: Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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