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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 초기 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yun Shi
- 전화번호: +8613717926522
- 이메일: zhyshiyun@126.com
연구 연락처 백업
- 이름: Xiyu Li
- 전화번호: +8619212951890
- 이메일: 18165120161@163.com
연구 장소
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Beijing, 중국
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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연락하다:
- Xueting Han
- 전화번호: +861084012709
- 이메일: dzmyyec@126.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: Healthy control group
healthy people |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum Anti-Müllerian Hormone (AMH) Level
기간: 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)
기간: 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
기간: 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
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Serum Estradiol (E2)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pregnancy Rate
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2025DZMEC-450-03
- 2025DZMEC-450-03 (기타 식별자: Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .