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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Première phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yun Shi
- Numéro de téléphone: +8613717926522
- E-mail: zhyshiyun@126.com
Sauvegarde des contacts de l'étude
- Nom: Xiyu Li
- Numéro de téléphone: +8619212951890
- E-mail: 18165120161@163.com
Lieux d'étude
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Beijing, Chine
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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Contact:
- Xueting Han
- Numéro de téléphone: +861084012709
- E-mail: dzmyyec@126.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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. |
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Aucune intervention: Healthy control group
healthy people |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
Délai: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum Anti-Müllerian Hormone (AMH) Level
Délai: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Serum Luteinizing Hormone (LH)
Délai: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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FSH/LH Ratio
Délai: From baseline to 3 months after treatment initiation
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Change in FSH/LH ratio before and after treatment. |
From baseline to 3 months after treatment initiation
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Serum Estradiol (E2)
Délai: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Traditional Chinese Medicine Syndrome Score
Délai: before and 1 month after the treatment
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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
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Modified Kupperman Menopausal Index (KMI)
Délai: before and 1 month after the treatment
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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
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Incidence of Treatment-Emergent Adverse Events
Délai: From baseline to 3 months after treatment initiation
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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
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HO-1
Délai: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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NQO1
Délai: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
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CAT
Délai: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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SOD
Délai: From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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MDA
Délai: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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FTO
Délai: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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m6a
Délai: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pregnancy Rate
Délai: From baseline to 3 months after treatment initiation
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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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025DZMEC-450-03
- 2025DZMEC-450-03 (Autre identifiant: Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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