Premature Ovarian InsufficiencyEarly Phase 1JJGS and POINCT06102655
Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics
A Early Phase 1 study testing Jiajian Guishen Formulation in people with Premature Ovarian Insufficiency and Metabolomics, run by Shi Yun at 1 site in China.
Trial summary
1. Identify differential metabolites in POI patients. 2. Analysis of differential metabolites and their involved mechanism pathways. 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, Metabolomics, Traditional Chinese Medicine
- What is being tested?
- Jiajian Guishen Formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2023to 20 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- POI Inclusion Criteria:
- Patients diagnosed by Western medicine with premature ovarian insufficiency;
- Patients with Chinese medicine differentiation of kidney deficiency and liver depression;
- 18 ≤ patients' age ≤ 39 years;
- Patients who do not use other drugs during treatment;
- Patients who voluntarily participate in this study, sign an informed consent form, and agree to take the corresponding treatment plan.
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- The above five items must be met to be included in the POI patient group in this study.
- Healthy subjects inclusion criteria:
- 18 ≤ Age≤ 39 years old;
- menstrual regularity;
- There is no abnormality in sex hormone and AMH examination;
- Voluntarily participate in this research and sign the informed consent form;
- Those who match the general information such as age, height, and weight of the patients included in POI.
Who cannot join
- POI exclusion criteria:
- Patients with congenital gonadal dysplasia or a family history similar to "early menopause";
- POI patients with acquired organic lesions or ovarian surgery;
- Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months;
- Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;
- Patients who are breastfeeding or pregnant;
- Patients who are allergic to the drugs used in this study or have a history of previous allergy to traditional Chinese medicines.
- Those who met any of the above 5 criteria were excluded from this study. Healthy subjects were excluded as (1), (3), (4), (5).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency
- Identify differential metabolites in POI patients.
- Analysis of differential metabolites and their involved mechanism pathways.
- Conditions
- Premature Ovarian Insufficiency, Metabolomics, Traditional Chinese Medicine, Mechanism, Clinical Syndrome
- Being tested
- Jiajian Guishen Formulation
- Keywords
- Premature Ovarian Insufficiency, Metabolomics, Traditional Chinese Medicine, Mechanism, Clinical Syndrome
- 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.
Jiajian Guishen FormulationDrug
Jiajian Guishen Formulation is a formulation of Traditional Chinese Medicine.POI patients will be treat with Jiajian Guishen Formulation for three menstrual cycles; their blood samples are collected before and after treatment.No drug will be used in control group, and their blood samples are collected when join the experiment.
| Study group | Role | What they receive |
|---|---|---|
| treatment group（Jiajian Guishen Formulation） | Experimental | Jiajian Guishen Formulation is a traditional Chinese medicine, it will be used in POI patients for three menstrual cycles; their blood samples are collected before and after treatment. Receives: Drug: Jiajian Guishen Formulation |
| no-treatment control group | No intervention | healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
follicle stimulating hormone,FSH
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Secondary outcomes (15)
anti mullerian hormone, AMH
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Evaluation of the efficacy of Traditional Chinese Medicine symptoms
A sacle score to evalyate the symptoms, results of scores ranges from 0 to 108, higher scores mean more severe condition of POI.The main symptoms include menstrual cycle, menstrual flow reduction. Scoring criteria: ① normal menstrual cycle 0 points, 1-2 weeks ahead or behind the wrong 4 points, 2-3 weeks 8 points, more than 3 weeks 12 points; ② menstrual flow than the previous menstrual flow no change 0 points, menstrual flow reduction ≤ ⅓ 4 points, ⅓ < menstrual flow reduction ≤ ½ 8 points, menstrual flow reduction > ½ 12 points. Secondary symptoms included lumbar and knee pain, dizziness and tinnitus, loss of libido, increased urination, hot flashes and night sweats, and lower back and lower limb pain et. According to the degree of aggravation of symptoms, the total score was assigned as 0,2,4,8.
Measured: before and1 month after the treatment
Improved Kupperman Scale Scoring
A sacle score to evalyate the symptoms, results of scores ranges from 0 to 39, higher scores mean more severe condition of POI.Referring to the domestic modified Kupperman Symptom Scoring Criteria in Chinese Obstetrics and Gynecology, edited by Cao Zeyi, to observe and rate perimenopausal symptoms before and after treatment and to quantify the degree of decline in ovarian function.Entries include hot flashes and sweating, sensory abnormalities, insomnia, anxiety and depression, dizziness, fatigue, muscle and joint pain, headache, palpitations, ankylosis of the skin, sexual discomfort, and urinary irritation, with different coefficients for each entry, and according to the aggravating degree of the symptom, they are divided into 0, 1, 2, and 3 points, and the coefficients corresponding to the scoring of the degree of each item are multiplied by a fixed score of the symptom to add up to the total score.
Measured: before and 1 month after the treatment
estradiol, E2
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
luteinizing hormone, LH
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
testosterone, T
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
malondialdehyde
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
superoxide dismutase
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
reduced glutathione, GSH
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
ceruloplasmin
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
copper
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
metabolite level
Blood samples are collected before and after treatment.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Differential metabolites and their related indexes of mechanism pathways
The results of differential metabolites and their related indexes of mechanism pathways cann't be predicted until the metabolomics test finish, because the test include hundreds of metabolites. Metabolomics results will be tested by using liquid chromatography coupled with mass spectrometry (LC-MS) to identify potential markers.All multivariate analyses and modeling on the normalized data were carried out using software SIMCA-P. Supervised analysis (orthogonal partial least squares discriminate analysis, OPLS-DA) was applied to distinguish metabolic difference between normal group and POI group. SPSS 22.0 (SPSS Inc) software was used for receiver operating characteristic (ROC) curve analyses and binary logistic regression analyses. Then their related indexes of mechanism pathways will be tested in blood samples.
Measured: Differential metabolites will be tested on the 2~4th day of menstruation (amenorrhea patients before and after taking medication), related indexes of mechanism pathways will be tested after the analyses of differential metabolities
Number of participants with abnormal laboratory test of blood routine examination results
Blood samples are collected before and after treatment. white blood cell count (WBC), red blood cell (RBC) and platelet count/blood platelet count (PLT) are included.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Number of participants with abnormal Liver and kidney function (by laboratory test results)
Blood samples are collected before and after treatment. creatinine(CREA), uric acid (UA), alanine amiotransferase(AST), aspartate aminotransferase (AST) and γ-glutamyl transpeptadase (GGT) are included.
Measured: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start24 Jul 2023
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
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
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shi Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Yun, Dongzhimen Hospital, Beijing
- Investigators
- Yun Shi, Study director, Dongzhimen Hospital of Beijing University of Chinese MedicineKe Xu, Master, Principal investigator, Dongzhimen Hospital of Beijing University of Chinese MedicineJing yi Shao, Master, Study chair, Dongzhimen Hospital of Beijing University of Chinese MedicineXi yu Li, Bachelor, Study chair, Dongzhimen Hospital of Beijing University of Chinese MedicineQin yang Liu, Bachelor, Study chair, Dongzhimen Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102655
- Sponsor's protocol ID
- 2023DZMEC-290
- Other IDs
- 2023DZMEC-290-02
- Acronym
- JJGS and POI
- Status last verified
- Sep 2024
- First submitted
- 18 Oct 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT06102655
- Acronym / sponsor ID
- JJGS and POI / 2023DZMEC-290
- Conditions
- Premature Ovarian Insufficiency, Metabolomics, Traditional Chinese Medicine, Mechanism, Clinical Syndrome
- Keywords
- Premature Ovarian Insufficiency, Metabolomics, Traditional Chinese Medicine, Mechanism, Clinical Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Shi YunUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 26 Oct 2023 (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.
- Identify differential metabolites in POI patients.
- Analysis of differential metabolites and their involved mechanism pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group（Jiajian Guishen Formulation） | Experimental | Drug: Jiajian Guishen FormulationJiajian Guishen Formulation is a traditional Chinese medicine, it will be used in POI patients for three menstrual cycles; their blood samples are collected before and after treatment. |
| no-treatment 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 (13 listed)
- Patients diagnosed by Western medicine with premature ovarian insufficiency;
- Patients with Chinese medicine differentiation of kidney deficiency and liver depression;
- 18 ≤ patients' age ≤ 39 years;
- Patients who do not use other drugs during treatment;
- Patients who voluntarily participate in this study, sign an informed consent form, and agree to take the corresponding treatment plan.
Key exclusion criteria (8 listed)
- Patients with congenital gonadal dysplasia or a family history similar to "early menopause";
- POI patients with acquired organic lesions or ovarian surgery;
- Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months;
- Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;
- Patients who are breastfeeding or pregnant;
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 |
|---|---|---|
| Jiajian Guishen FormulationJiajian Guishen Formulation is a formulation of Traditional Chinese Medicine.POI patients will be treat with Jiajian Guishen Formulation for three menstrual cycles; their blood samples are collected before and after treatment.No drug will be used in control group, and their blood samples are collected when join the experiment. | Drug | treatment group（Jiajian Guishen Formulation） |
Primary outcome
follicle stimulating hormone,FSH
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Blood samples are collected before and after treatment.
15 secondary outcomes
anti mullerian hormone, AMH
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Evaluation of the efficacy of Traditional Chinese Medicine symptoms
Time frame: before and1 month after the treatment
Improved Kupperman Scale Scoring
Time frame: before and 1 month after the treatment
estradiol, E2
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
luteinizing hormone, LH
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
testosterone, T
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
malondialdehyde
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
superoxide dismutase
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
reduced glutathione, GSH
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
ceruloplasmin
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
copper
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
metabolite level
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Differential metabolites and their related indexes of mechanism pathways
Time frame: Differential metabolites will be tested on the 2~4th day of menstruation (amenorrhea patients before and after taking medication), related indexes of mechanism pathways will be tested after the analyses of differential metabolities
Number of participants with abnormal laboratory test of blood routine examination results
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Number of participants with abnormal Liver and kidney function (by laboratory test results)
Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- 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. This study is not recruiting at the moment.
Yun Shi study director
Dongzhimen Hospital of Beijing University of Chinese Medicine
Ke Xu, Master principal investigator
Dongzhimen Hospital of Beijing University of Chinese Medicine
Jing yi Shao, Master study chair
Dongzhimen Hospital of Beijing University of Chinese Medicine
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 Jiajian Guishen Formulation in people with Premature Ovarian Insufficiency and Metabolomics, 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 13 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follicle stimulating hormone,FSH (time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)). 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 5 Dec 2024.