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.
調査の概要
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Yun Shi
- 電話番号：+8613717926522
- メール：zhyshiyun@126.com
研究連絡先のバックアップ
- 名前：Xiyu Li
- 電話番号：+8619212951890
- メール：18165120161@163.com
研究場所
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Beijing、中国
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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コンタクト：
- Xueting Han
- 電話番号：+861084012709
- メール：dzmyyec@126.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：Healthy control group
healthy people |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum Follicle-Stimulating Hormone (FSH)
時間枠：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum Anti-Müllerian Hormone (AMH) Level
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
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HO-1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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FTO
時間枠：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
時間枠：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pregnancy Rate
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025DZMEC-450-03
- 2025DZMEC-450-03 (その他の識別子：Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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