A Randomized Controlled Clinical Trial of Acupuncture in Nourishing Kidney and Dredging Fu Organs for Functional Constipation in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period
研究概览
简要总结
Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs".
详细描述
Functional constipation is a common disease of old people. To date, there has not specific therapy on it. Former research showed acupuncture may work for functional constipation. In the trial, patients in the acupuncture and sham acupuncture groups will receive 24 acupuncture treatments over an 8-week period. This RCT is designed to confirm the efficacy and safety of acupuncture in functional constipation treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Rome IV Diagnostic Criteria for Constipation and TCM Diagnostic Criteria of constipation with yin deficiency syndrome;
- •No gender restriction, age 60-80;
- •FC that is classified as mild or moderate;
- •Have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment);
- •Have not participated in other medical clinical trials over the past one month;
- •Those who can understand various evaluation scales, complete the evaluation and cooperate with the completion of the planned course of treatment;
- •Sign the informed consent.
排除标准
- •Irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs;
- •Constipation caused by organic diseases;
- •Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases;
- •Those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances;
- •Patients with cognitive impairment or aphasia;
- •Those who take other drugs during treatment, which affect the efficacy and judgment (except emergency treatment).
结局指标
主要结局
The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period
时间窗: At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).
Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation.
次要结局
- Patient Assessment of Constipation-Symptoms (PAC-SYM)(At baseline and at week 8 (end of treatment).)
- Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)(At baseline and at week 8 (end of treatment).)
- Self-rating Anxiety Scale（SAS）(At baseline and at week 8 (end of treatment).)
- Self-rating Depression Scale（SDS）(At baseline and at week 8 (end of treatment).)
- Bristol Stool Scale(At baseline and at week 8 (end of treatment).)
- Incidence of adverse events(During 1-8 weeks)
- Weekly usage of emergency bowel medications(At baseline and at week 8 (end of treatment).)
研究者
Yin Ping
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine