- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07598227
Moxibustion for Nocturia
2026년 5월 17일 업데이트: Buddhist Tzu Chi General Hospital
Evaluation of the Efficacy and Safety of Acupoint Moxibustion for Nocturia: A Pilot Study
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night.
Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions.
This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.
연구 개요
상세 설명
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night.
Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions.
This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.
Using voiding diaries, the International Prostate Symptom Score (IPSS), the Overactive Bladder Symptom Score (OABSS), and Quality of Life (QoL) assessments, this study aimed to provide a cost-effective and clinically feasible complementary and alternative therapy.
Furthermore, the TCM constitutional characteristics of nocturia patients were analyzed through the Constitution in Chinese Medicine Questionnaire (CCMQ) combined with evaluations of abdominal muscle tension.
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yen-Lun Kung
- 전화번호: +886-3-8561825
- 이메일: kung818@gmail.com
연구 장소
-
-
-
Hualien City, 대만
- 모병
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
-
연락하다:
- Yen-Lun Kung
- 이메일: kung818@gmail.com
-
-
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Patients aged 40 years or older.
- Experiencing two or more nocturia episodes per night.
Exclusion Criteria
- Active urinary tract infection (UTI).
- Poorly controlled diabetes mellitus (defined as HbA1c > 6.5%).
- Presence of a neurogenic bladder caused by conditions such as multiple sclerosis, Parkinson's disease, stroke, spinal cord injury, or nerve damage resulting from major pelvic surgery.
- Severe congestive heart failure (New York Heart Association [NYHA] functional class > II).
- Use of other Traditional Chinese Medicine (TCM) therapies for nocturia symptoms within the past month (30 days).
- Pregnant women.
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 제어
|
|
|
실험적: 뜸
|
Apply moxibustion on acupoint
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
frequency of nocturia
기간: Baseline and Week 3 and Week 6
|
Baseline and Week 3 and Week 6
|
|
nocturnal urine volume
기간: Baseline and Week 3 and Week 6
|
Baseline and Week 3 and Week 6
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
International Prostate Symptom Score (IPSS)
기간: Baseline and Week 3 and Week 6
|
Total score on the International Prostate Symptom Score (IPSS).
The scale ranges from 0 to 35, where higher scores indicate more severe symptoms (worse outcome).
|
Baseline and Week 3 and Week 6
|
|
Overactive Bladder Symptom Score (OABSS)
기간: Baseline and Week 3 and Week 6
|
Total score on the Overactive Bladder Symptom Score (OABSS).
The OABSS is a four-item questionnaire assessing daytime frequency, nighttime frequency, urgency, and urgency incontinence.
The total score ranges from 0 to 15, where higher scores indicate more severe overactive bladder symptoms (worse outcome).
|
Baseline and Week 3 and Week 6
|
|
Quality of Life (QoL)
기간: Baseline and Week 3 and Week 6
|
The International Prostate Symptom Score (IPSS) Quality of Life (QoL) is a single-item questionnaire that assesses the patient's perceived satisfaction with their current urinary symptoms.
Patients answer the question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?"
The score ranges from 0 to 6, where 0 represents "delighted" and 6 represents "terrible."
A higher score indicates a poorer quality of life (worse outcome).
|
Baseline and Week 3 and Week 6
|
|
Pittsburgh Sleep Quality Index (PSQI)
기간: Baseline and Week 3 and Week 6
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to assess sleep quality over a one-month time interval.
It consists of 19 individual items which are used to generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The sum of these seven component scores yields one global score.
The global PSQI score ranges from 0 to 21, where 0 indicates no difficulty and 21 indicates severe difficulties in all areas.
A higher score indicates poorer sleep quality (worse outcome).
|
Baseline and Week 3 and Week 6
|
|
Abdominal muscle tension
기간: Baseline and Week 3 and Week 6
|
Muscle tone (tension) is measured using the MyotonPRO digital palpation device.
The frequency (F) is calculated based on the oscillations of the muscle tissue after a mechanical impulse.
The unit of measure is Hertz (Hz).
A higher frequency indicates higher muscle tone (increased tension), which in the context of this study represents a worse outcome (abdominal tension).
|
Baseline and Week 3 and Week 6
|
|
Abdominal muscle stiffness
기간: Baseline and Week 3 and Week 6
|
Dynamic stiffness (S) is measured using the MyotonPRO digital palpation device.
Stiffness (S) represents the ability of the muscle tissue to resist an external force.
The unit of measure is Newtons per meter (N/m).
A higher value indicates a stiffer or more rigid muscle, representing a worse outcome (increased abdominal rigidity).
|
Baseline and Week 3 and Week 6
|
|
Abdominal muscle elasticity
기간: Baseline and Week 3 and Week 6
|
Muscle elasticity is measured using the MyotonPRO digital palpation device.
The logarithmic decrement (D) represents the muscle's ability to recover its shape after deformation (elasticity).
This is a dimensionless value.
A higher decrement value indicates lower elasticity and a longer recovery time, representing a worse outcome (reduced tissue elasticity).
|
Baseline and Week 3 and Week 6
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 1월 1일
기본 완료 (추정된)
2026년 12월 31일
연구 완료 (추정된)
2026년 12월 31일
연구 등록 날짜
최초 제출
2026년 3월 4일
QC 기준을 충족하는 최초 제출
2026년 5월 17일
처음 게시됨 (실제)
2026년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 17일
마지막으로 확인됨
2026년 3월 1일
추가 정보
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. .