Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress (JJGS ; POI)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Tidig fas 1
Kontakter och platser
Studiekontakt
- Namn: Yun Shi
- Telefonnummer: +8613717926522
- E-post: zhyshiyun@126.com
Studera Kontakt Backup
- Namn: Xiyu Li
- Telefonnummer: +8619212951890
- E-post: 18165120161@163.com
Studieorter
-
-
-
Beijing, Kina
- Dongzhimen Hospital, Beijing University of Chinese Medicine
-
Kontakt:
- Xueting Han
- Telefonnummer: +861084012709
- E-post: dzmyyec@126.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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. |
|
Inget ingripande: Healthy control group
healthy people |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serum Follicle-Stimulating Hormone (FSH)
Tidsram: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serum Anti-Müllerian Hormone (AMH) Level
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pregnancy Rate
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025DZMEC-450-03
- 2025DZMEC-450-03 (Annan identifierare: Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .