An Early Phase 1 interventional study of JJGS in Premature Ovarian Insufficiency, sponsored by Shi Yun. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Shi Yun · Early Phase 1, Interventional, and Treatment
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.
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
This study's planned enrollment of 45 is close to the median of 48 across 113 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Shi Yun is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 . 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 people
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.
Serum Follicle-Stimulating Hormone (FSH)
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Serum Anti-Müllerian Hormone (AMH) Level
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
FSH/LH Ratio
Change in FSH/LH ratio before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Serum Estradiol (E2)
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Traditional Chinese Medicine Syndrome Score
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.
Time frame: before and 1 month after the treatment
Modified Kupperman Menopausal Index (KMI)
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.
Time frame: before and 1 month after the treatment
Incidence of Treatment-Emergent Adverse Events
The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.
Time frame: From baseline to 3 months after treatment initiation
HO-1
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
NQO1
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
CAT
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
SOD
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
MDA
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
FTO
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
m6a
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Pregnancy Rate
The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.
Time frame: From baseline to 3 months after treatment initiation
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Primary Ovarian Insufficiency →
Shi Yun