- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07589036
Effects of Dioscorea Yam Gruel on Blood Lipid Profiles in PCI Patients With Coronary Heart Disease
Effects of Dioscorea Yam Gruel on Blood Lipid Profiles in PCI Patients With Coronary Heart Disease: A Randomized Controlled Trial
연구 개요
상세 설명
Background:
Percutaneous coronary intervention (PCI) is an important revascularization strategy for coronary heart disease, but it cannot reverse the fundamental pathological process of atherosclerosis. Dyslipidemia is a core risk factor for disease progression. This study aimed to investigate the effects of Dioscorea yam gruel, a traditional Chinese dietary therapy, on blood lipid levels in patients after PCI.
Methods (Brief Outline):
Seventy-two post-PCI patients were randomized 1:1 to control (standard care) or intervention (standard care plus 150 g/day Dioscorea yam gruel for 12 weeks). Lipid profiles were assessed at baseline, 8 weeks, and 12 weeks. Body mass index (BMI) was measured at baseline and 12 weeks.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Fujian
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Fuzhou, Fujian, 중국, 350025
- 900th Hospital of PLA Joint Logistic Support Force
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Meeting the diagnostic criteria for coronary heart disease (2020 edition)
- Undergoing percutaneous coronary intervention (PCI)
- Aged between 18 and 75 years
- Having been on a stable dose of statin therapy for at least 4 weeks prior to screening
- Being in a stable clinical condition, conscious, providing informed consent, and participating voluntarily
Exclusion Criteria:
- Low-density lipoprotein cholesterol (LDL-C) level < 70 mg/dL(<1.81mmol/L) at screening
- Complicating with other severe diseases or diseases that affect blood lipid levels, such as malignant tumors, acute cerebrovascular disease, nephrotic syndrome, severe liver disease, Cushing's syndrome, and others
- Pregnancy or lactation
- Concurrently participating in other dietary or exercise intervention programs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Standard Care Group
Patients received standard post-procedural treatment and care, including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks
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Standard post-procedural treatment and care including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks
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실험적: Dioscorea Yam Gruel Group
In addition to all interventions received by the control group, patients consumed approximately 150 g of Dioscorea yam gruel daily as a partial dinner replacement for 12 consecutive weeks
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In addition to receiving all standard post-PCI care (weekly health education lectures and routine 4-week follow-up), patients consumed approximately 150 g of Dioscorea yam gruel daily as a partial dinner replacement for 12 consecutive weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Lipid Profile
기간: Baseline, Week 8, Week 12
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Serum levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) were measured at baseline, 8 weeks, and 12 weeks of the intervention
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Baseline, Week 8, Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Mass Index (BMI)
기간: Baseline, Week 12
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Body mass index was measured at baseline and at 12 weeks post-intervention.
Height and weight were measured using a standard stadiometer and scale.
BMI was calculated as weight in kilograms divided by the square of height in meters (kg/m^2)
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Baseline, Week 12
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-05
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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