The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
2026년 5월 5일 업데이트: Peking Union Medical College Hospital
This study aims to validate the efficacy and safety of the "two-step cycle-regulating approach integrating Chinese and Western medicine: rapid restoration of menstruation with Western medicine, and nourish the kidney and soothe the liver, nourishing the essence, and reinforcing the vital essence and strengthening the primordial qi with Chinese medicine" through a nationwide randomized controlled clinical trial involving 210 cases.
Guided by traditional Chinese medicine theory, the study will explore the mechanism of integrated Chinese and Western medicine in the treatment of functional hypothalamic amenorrhea through gut microbiota and metabolomics research.
연구 개요
연구 유형
중재적
등록 (추정된)
210
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yan Deng, Doctor
- 전화번호: 86+010-69158331
- 이메일: yanndeng@163.com
연구 장소
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Beijing, 중국, 100730
- 모병
- Peking Union Medical College Hospital
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연락하다:
- Yan Deng, Doctor
- 전화번호: 01069158331
- 이메일: yanndeng@163.com
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수석 연구원:
- Aijun Sun, Doctor
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
Diagnostic criteria for functional hypothalamic amenorrhea
- primary or secondary amenorrhea
- Normal or low FSH levels, LH < 5 IU/L, E2 < 50 pg/mL
- Exclusion of amenorrhea caused by: -Organic lesions of the hypothalamus or pituitary gland , Ovarian amenorrhea , Uterine or lower genital tract developmental abnormalities ,Drug-induced amenorrhea ,Other causes of amenorrhea
Exclusion Criteria:
- Individuals who have used relevant medications within the past 3 months
- History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
- Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients
- Lactating or pregnant women, or females within one year postpartum
- History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
- Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
- History of thromboembolic disease or thrombotic tendency.
- Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Femoston group
Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.
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Western medicine（Femoston 2/10)
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실험적: Ba Zhen Yi Mu Pill and Ding Kun Dan group
Participants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently.
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traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
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실험적: Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group
Participants in the intervention group received Ba Zhen Yi Mu Pill (6 g twice daily), Ding Kun Dan (7g twice daily), and Femoston (estradiol 2mg / dydrogesterone 10mg, 1 tablet daily) concurrently.
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Western medicine（Femoston 2/10)
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Menstrual patterns during treatment and after discontinuation
기간: From enrollment, during the treatment of 6 months, and within 3 months after treatment
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Document the number of episodes of menstruation during the treatment and follow-up period
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From enrollment, during the treatment of 6 months, and within 3 months after treatment
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Sex hormone levels
기간: from enrollment to the end of treatment at 6 months
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Measure the levels of sex hormones in the blood, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Dehydroepiandrosterone Sulfate (DHEA-S), and Anti-Müllerian Hormone (AMH).
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from enrollment to the end of treatment at 6 months
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Uterine volume
기간: From enrollment to the end of treatment at 6 months
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Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 × L × W × AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound.
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From enrollment to the end of treatment at 6 months
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Quality of Life Score(36-Item Short Form Health Survey，SF 36)
기간: From enrollment to the end of treatment at 6 months
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The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
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From enrollment to the end of treatment at 6 months
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Total ovarian volume
기간: from enrollment to the end of treatment at 6 months
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Total ovarian volume (cm³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 × length × width × thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound.
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from enrollment to the end of treatment at 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
기간: From enrollment to 3 months after the end of treatment
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Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II).
Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome).
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From enrollment to 3 months after the end of treatment
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Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
기간: From enrollment to 3 months after the end of treatment
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Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms (worse outcome).
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From enrollment to 3 months after the end of treatment
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Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
기간: From enrollment to 3 months after the end of treatment
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Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10).
Total scores range from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).
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From enrollment to 3 months after the end of treatment
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Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26)
기간: From enrollment to 3 months after the end of treatment
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Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) .
Total scores range from 0 to 78 , with higher scores indicating more disordered eating pathology (worse outcome) .
A score of 20 or higher is considered indicative of an elevated risk for an eating disorder, warranting further clinical evaluation
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From enrollment to 3 months after the end of treatment
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
기간: From enrollment to the end of treatment at 6 months
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Participants were followed up at the hospital every 3 months during the treatment period.
At each follow-up visit, adverse events (AEs) were documented, and their causality (relationship to the treatment) was assessed by the investigators.
The severity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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From enrollment to the end of treatment at 6 months
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Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
기간: From enrollment to 3 months after the end of treatment.
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Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
Elevated ALT levels indicate hepatocellular injury (worse outcome).
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From enrollment to 3 months after the end of treatment.
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Renal function was assessed by measuring serum creatinine (SCr) levels
기간: From enrollment to 3 months after the end of treatment
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Renal function was assessed by measuring serum creatinine (SCr) levels.
Serum creatinine levels were measured, with higher levels indicating worse renal function (worse outcome) .
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From enrollment to 3 months after the end of treatment
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Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .
기간: From enrollment to 3 months after the end of treatment
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Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .
Total physical activity was calculated as metabolic equivalent of task (MET)-minutes per week, ranging from 0 to 14,280 MET-minutes/week (theoretical maximum), with higher scores indicating greater physical activity levels (better outcome) .
Total sitting time was recorded as minutes per week, ranging from 0 to 1,440 minutes/week, with higher scores indicating more sedentary behavior (worse outcome) .
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From enrollment to 3 months after the end of treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 10월 22일
기본 완료 (추정된)
2028년 6월 30일
연구 완료 (추정된)
2028년 6월 30일
연구 등록 날짜
최초 제출
2026년 4월 27일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2025년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025YFC3508004 (기타 보조금/기금 번호: National Key Research and Development Program of China)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
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