Clinical study for the acupuncture with regulating mind and spleen regulation of brain structure and function in IBS-D patients based on multimodal fMRI.

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•Inclusion criteria for IBS-D patients:
•(1) meet the IBS-D Rome IV diagnostic criteria;
•(2) right-handed;
•(3) men and women aged 18–70 years;
•(4) lack of morphological changes and biochemical abnormalities that could explain the symptoms;
•(5) baseline IBS-Symptom Severity Score (IBS-SSS) score of 75 points or greater;
•(6) no medication for IBS has been used for at least 2 weeks(except for emergency treatment), no acupuncture treatment for 3 months preceding the trial,and no participation in any other ongoing clinical trial;
•(7) agreement to participate and signing of the informed consent document.
•Inclusion criteria for healthy volunteers:
•(1) right-handed;
•(2) aged 18–70 years;
•(3) have a healthy body (no gastrointestinal symptoms, physical pain and discomfort, no congenital lesions, organic lesions and functional diseases);
•(4) no claustrophobia;
•(5) no metal substances in the body that can affect fMRI;
•(6) no genetic history of family mental illness;
•(7) female volunteers are not in menstruation, pregnancy, postpartum lactation;
•(8) agreement to participate and signing of the informed consent document.

•Exclusion criteria for IBS-D patients:
•(1) intestinal organic lesions, or systemic diseases that affect gastrointestinal motility (such as gallbladder pancreatitis, hyperthyroidism, diabetes, chronic renal insufficiency, neurological disorders);
•(2) combined with serious primary diseases such as cardiovascular system, liver, kidney, hematopoietic system, mental illness, and cognitive impairment;
•(3) history of abdominal or rectal anus surgery;
•(4) frequently taking drugs or preparations that affect gastrointestinal motility or alter intestinal function;
•(5) pregnancy, lactation, postpartum <=12 months and allergies;
•(6) use other treatments or other drugs at the same time, which can influence the efficacy or safety judgment.
•(7) patient refused to participate in the observation or contained other unstable factors. For example, taking other drugs that affect the efficacy observation can not judge the effect or lead to incomplete data;
•(8) those with metal allergy or severe fear;
•(9) someone is equipped with metal materials that cannot be removed (such as cardiac pacemakers, metal prostheses, etc.), and those who have claustrophobia can not perform fMRI.

发起方

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine