Premature Ovarian InsufficiencyEarly Phase 1JJGS ; POINCT07843030
Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress
A Early Phase 1 study testing JJGS in people with Premature Ovarian Insufficiency, run by Shi Yun at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- JJGS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing
Xueting Han, +861084012709, dzmyyec@126.com
About this study
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.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- JJGS
- Keywords
- premature ovarian insufficiency, traditional Chinese medicine, oxidative stress
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JJGS |
| Healthy control group | No intervention | healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Follicle-Stimulating Hormone (FSH)
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
Secondary outcomes (14)
Serum Anti-Müllerian Hormone (AMH) Level
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
FSH/LH Ratio
Change in FSH/LH ratio before and after treatment.
Measured: From baseline to 3 months after treatment initiation
Serum Estradiol (E2)
Blood samples are collected before and after treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 3 months after treatment initiation
HO-1
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
NQO1
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
CAT
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
SOD
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
MDA
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
FTO
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
m6a
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Yun, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843030
- Sponsor's protocol ID
- 2025DZMEC-450-03
- Other IDs
- 2025DZMEC-450-03
- Acronym
- JJGS ; POI
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress
- ClinicalTrials.gov ID
- NCT07843030
- Acronym / sponsor ID
- JJGS ; POI / 2025DZMEC-450-03
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- premature ovarian insufficiency, traditional Chinese medicine, oxidative stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shi YunUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| JJGS treatment group | Experimental | Drug: JJGSJJGS is a traditional Chinese medicine formula administered to patients with POI for three menstrual cycles. Blood samples will be collected before and after treatment. |
| Healthy control group | No intervention | –healthy people |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JJGSJJGS 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. | Drug | JJGS treatment group |
Primary outcome
Serum Follicle-Stimulating Hormone (FSH)
Time frame: From baseline to 3 months after treatment initiation
Blood samples are collected before and after treatment.
14 secondary outcomes
Serum Anti-Müllerian Hormone (AMH) Level
Time frame: From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)
Time frame: From baseline to 3 months after treatment initiation
FSH/LH Ratio
Time frame: From baseline to 3 months after treatment initiation
Serum Estradiol (E2)
Time frame: From baseline to 3 months after treatment initiation
Traditional Chinese Medicine Syndrome Score
Time frame: before and 1 month after the treatment
Modified Kupperman Menopausal Index (KMI)
Time frame: before and 1 month after the treatment
Incidence of Treatment-Emergent Adverse Events
Time frame: From baseline to 3 months after treatment initiation
HO-1
Time frame: From baseline to 3 months after treatment initiation
NQO1
Time frame: From baseline to 3 months after treatment initiation
CAT
Time frame: From baseline to 3 months after treatment initiation
SOD
Time frame: From baseline to 3 months after treatment initiation
MDA
Time frame: From baseline to 3 months after treatment initiation
FTO
Time frame: From baseline to 3 months after treatment initiation
m6a
Time frame: From baseline to 3 months after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JJGS in people with Premature Ovarian Insufficiency, run by Shi Yun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Shi (+8613717926522, zhyshiyun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Follicle-Stimulating Hormone (FSH) (time frame: From baseline to 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.