Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Pain sensitivity
研究概览
简要总结
Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS.
详细描述
This study intends to include 50 healthy volunteers and 50 patients with IBS. The study objects are healthy volunteers and patients diagnosed with IBS from the Third Affiliated Hospital of Zhejiang Chinese Medicine University and social recruitment. This study is observational and does not involve randomized methods. At the same time, there is no blindness for subjects, indicators detection and input. The observation indexes were pain sensitivity, thermal radiation characteristics, microcirculation characteristics, biological ultra-weak luminescence, electrical characteristics, intestinal flora characteristics, tryptophan metabolites level and related scales at common acupoints of irritable bowel syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for healthy volunteers:
- •18 years old ≤ age ≤75 years old, gender is not limited;
- •No inflammatory bowel disease, lactose intolerance, intestinal bacterial overgrowth, parasitic infection, drug induced enteritis and other intestinal diseases;
- •No abdominal pain, frequency of defecation and changes in fecal characteristics in 1 week;
- •Provide healthy subjects with no obvious abnormalities reported by colonoscopy in the past 1 year;
- •Healthy subjects who can provide medical examination reports within the past 1 year and have routine physical examination conducted by researchers to confirm that there are no heart and lung diseases, digestive, urinary, blood, endocrine, nervous system and other serious underlying diseases;
- •No antidiarrheal drugs, antibiotics, gastrointestinal motility drugs or other related drugs affecting clinical studies within 4 weeks;
- •Clear consciousness, can complete normal communication;
- •Understands and is willing to comply with the research protocol and sign the informed consent.
- •Inclusion criteria for IBS patients:
- •Patients who can provide colonoscopy report in the past 1 year and meet the Rome IV standard of irritable bowel syndrome and TCM syndrome differentiation type;
- •Provide medical examination reports within the past 1 year to confirm patients without digestive, circulatory, respiratory, urinary, reproductive, endocrine, nervous system and other malignant tumors and serious underlying diseases;
- •18 years old ≤ age ≤75 years old, gender is not limited;
- •No antidiarrheal drugs, antibiotics, gastrointestinal motility drugs or other related drugs that affect clinical studies have been taken within 4 weeks;
- •Clear consciousness, can complete normal communication;
- •Understands and is willing to comply with the research protocol and sign the informed consent.
排除标准
- •Exclusion criteria for healthy volunteers:
- •Those who have mental illness, alcohol dependence or a history of drug abuse and cognitive impairment are unable to cooperate with the examination and understanding of the subject;
- •Female volunteers who are pregnant or lactating, or in ovulation and menstruation period;
- •Volunteers with current abnormal body temperature;
- •Subjects currently participating in other clinical trials.
- •Exclusion criteria for patients with IBS:
- •Those who have mental illness, alcohol dependence or a history of drug abuse and cognitive impairment are unable to cooperate with the examination and understanding of the subject;
- •Pregnant or lactating women or female subjects in ovulation and menstruation period;
- •Patients with inflammatory bowel disease, lactose intolerance, intestinal bacterial overgrowth, parasitic infections, drug-induced enteritis and other intestinal diseases;
- •Patients with intestinal diseases such as functional constipation, functional diarrhea, opioid-induced constipation, and non-specific functional bowel disease;
- •Patients with functional gastrointestinal diseases such as functional dyspepsia, functional heartburn, central abdominal pain syndrome;
- •Patients with current abnormal body temperature;
- •Participants who are currently participating in other clinical trials.
结局指标
主要结局
Pain sensitivity
时间窗: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
Select the measurement point, place the probe of the handheld pain threshold testing instrument vertically on the pain measurement point, slowly and steadily press, and stop the pressure when the subject feels pain (or the subject can stop the pressure). At this point, the reading on the monitor is the subject's pain threshold. After the measurement is completed, press the zero button to measure the next point or the next subject.
Microcirculation characteristics
时间窗: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
The PeriCam PSI laser speckle imager was adopted to store and record the speckle imaging images and curves with the support of PIM Soft computer software, and the blood flow data was analyzed, the blood flow values of the corresponding acupoints were extracted, and the average perfusion volume of the acupoints within 2 minutes was calculated as the perfusion volume index.
Biological ultra-weak luminescence
时间窗: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
It is divided into the UPE detection system of photomultiplier tube (PMT) and the UPE image acquisition system of charge coupled device (CCD).PMT: The data of each measurement point is the self-luminous intensity of the subject per second.CCD: The image acquisition software Andor Solis is used to store the captured CCD image, analyze the ultra-weak luminescence data of the acquisition site, and extract the average value of the ultra-weak luminescence of the corresponding position as its basic value.
Thermal radiation characteristics
时间窗: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
The NEC R550 infrared thermal imager and the InfRec Analyzer NS9500 computer software were used to store and save the infrared thermal images taken, and the temperature data were analyzed, the temperature values of relevant acupoints in corresponding coordinates were extracted, and the average temperature values of acupoints in the 6 infrared thermal images were calculated as their basic temperatures.
Electrical characteristics
时间窗: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
Meridian point resistance meter was used to measure the point resistance, each point was detected for 5 minutes, the data was stored and analyzed by excel2019, the relative resistance value of the corresponding point was extracted, and the average resistance value of the point was calculated within 5 minutes.
次要结局
- Self-Rating Depression Scale (SDS)(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- Pittsburgh Sleep Quality Index (PSQI)(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- Intestinal flora(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- Tryptophan metabolites(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- Gastrointestinal Symptoms Rating Scale (GSRS)(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- IBS Quality of Life (IBS-QOL )(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- Bristol Fecal Traits Grading Scale(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- Severity of IBS (IBS-SSS)(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- TCM Constitution Survey(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
- Self-Rating Anxiety Scale (SAS)(the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment))
研究者
Xiaomei Shao
Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University