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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase inicial 1
Contactos e Locais
Contato de estudo
- Nome: Yun Shi
- Número de telefone: +8613717926522
- E-mail: zhyshiyun@126.com
Estude backup de contato
- Nome: Xiyu Li
- Número de telefone: +8619212951890
- E-mail: 18165120161@163.com
Locais de estudo
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Beijing, China
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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Contato:
- Xueting Han
- Número de telefone: +861084012709
- E-mail: dzmyyec@126.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Sem intervenção: Healthy control group
healthy people |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Serum Anti-Müllerian Hormone (AMH) Level
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pregnancy Rate
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025DZMEC-450-03
- 2025DZMEC-450-03 (Outro identificador: Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
Plano para dados de participantes individuais (IPD)
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Informações sobre medicamentos e dispositivos, documentos de estudo
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