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NCT Number: NCT07843030

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

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.

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Key information

Conditions

Premature Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Serum Follicle-Stimulating Hormone (FSH)

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

Secondary outcomes

  1. Serum Anti-Müllerian Hormone (AMH) Level

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  2. Serum Luteinizing Hormone (LH)

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  3. FSH/LH Ratio

    Time frame: From baseline to 3 months after treatment initiation

    Change in FSH/LH ratio before and after treatment.

  4. Serum Estradiol (E2)

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  5. 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.

  6. 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.

  7. 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.

  8. HO-1

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  9. NQO1

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  10. CAT

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  11. SOD

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  12. MDA

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  13. FTO

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  14. m6a

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

Other outcomes

  1. 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.

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Sponsors and collaborators

Lead sponsor

Shi Yun

Other

Registry information

Acronym: JJGS ; POI

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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