Diarrheal irritable bowel syndrome
Conditions
Interventions
Moxibustion group:Refer to the national standard of the People's Republic of China "Name and Location of acupoints" (GB/T 12346-2006) to locate the following acupoints.
Point selection: Zhongwan, bila
Operation: All patients were supine and all acupoints were routinely disinfected.The refined moxa stick with a diameter of 3cm (Nanyang Hanyi Moxa Pile Co., LTD.) was placed on a moxibustion rack and
Western medicine group:According to the 2020 Expert Consensus Opinion on Irritable Bowel Syndrome in China, loperamide hydrochloride (idiamide, 2mg, Sinopyma H10910085, Xi 'an Janssen Pharmaceutical)
Female health control group:None
Sponsors
Shanghai Research Institute of Acupuncture and Meridian
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: Female IBS-D subjects: (1) Patients with IBS-D who meet the definition of Rome IV and the 2020 Chinese Expert Consensus Opinion on Irritable Bowel Syndrome; (2) Female, 18 = age =49 years old; (3) Weekly abdominal pain score =3 points (0-10 scale); (4) Understand and agree to participate in this study and sign the informed consent. Female health Subjects: (1) The subjects did not have abdominal pain, abdominal distension, abdominal discomfort, changes in stool characteristics and frequency; (2) Female, 18 = age =49 years old; (3) Understand and agree to participate in this study and sign the informed consent. Male IBS-D subjects: (1) Patients with IBS-D who meet the definition of Rome IV and the 2020 Chinese Expert Consensus Opinion on Irritable Bowel Syndrome; (2) Male, 18 = age =49 years old; (3) Weekly abdominal pain score =3 points (0-10 scale); (4) Understand and agree to participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: Female IBS-D subjects: (1) Patients with organic intestinal lesions or post-infection IBS-D; (2) Age >40 years old, irregular menstrual cycle more than 6 months;Or =40 years old, irregular menstrual cycle for more than 1 year;Patients after hysterectomy or bilateral salpingo-oophorectomy;Or patients with gynecological organic diseases; (3) Patients with severe heart, brain, liver, kidney and other diseases and malignant tumors; (4) Patients with mental diseases; (5) Patients with a history of secondary gastrointestinal surgery or gastrointestinal resection; (6) Patients who used IBS-D drugs within 2 months prior to enrollment; (7) Participants who had participated or were participating in other clinical trials within 1 month before enrollment; (8) There are skin diseases, limb mutilation and other conditions in the acupuncture point area selected in this study, and moxibustion cannot be applied; (9) Patients who are allergic to the Western medicine used in this study or excluded from the instructions of Western medicine; (10) Pregnant and lactating patients; (11) People who have taken any food (such as probiotics, lactic acid bacteria drinks, anti-diarrhea agents, gastrointestinal motonics, antibiotics, traditional Chinese medicine, etc.) in the past three months that affect the test indexes involved in this study. Female health Subjects: (1) Subjects with organic intestinal lesions, or with a history of secondary gastrointestinal surgery or gastrointestinal resection; (2) Age >40 years old, irregular menstrual cycle more than 6 months;Or =40 years old, irregular menstrual cycle for more than 1 year;Patients after hysterectomy or bilateral salpingo-oophorectomy;Or patients with gynecological organic diseases; (3) Patients with severe heart, brain, liver, kidney and other diseases and malignant tumors; (4) Patients with mental diseases; (5) Participants who had participated or were participating in other clinical trials within 1 month before enrollment; (6) Subjects during pregnancy and lactation; (7) People who have taken any food (such as probiotics, lactic acid bacteria drinks, antidiarrhea agents, gastrointestinal motonics, antibiotics, traditional Chinese medicine, etc.) in the past three months that affect the test indexes involved in this study. Male IBS-D subjects: (1) Patients with organic intestinal lesions or post-infection IBS-D; (2) Patients with severe heart, brain, liver, kidney and other diseases and malignant tumors; (3) Patients with mental diseases; (4) Patients with a history of secondary gastrointestinal surgery or gastrointestinal resection; (5) Participants who had participated or were participating in other clinical trials within 1 month before enrollment; (6) People who have taken any food (such as probiotics, lactic acid bacteria drinks, antidiarrhea agents, gastrointestinal motonics, antibiotics, traditional Chinese medicine, etc.) in the past three months that affect the test indexes involved in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate at week 6 of intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other metrics defined based on the composite response rate (composite response rate for week 12;Comparison of repeated measurements of comprehensive response rates at 3, 6, 9 and 12 weeks);IBS symptom severity scale;IBS quality of life scale;Visual Analogue Scale;Emotional status Assessment (Hospital Anxiety and Depress Scale);Safety assessment;Laboratory tests (serum GR, CRH, ACTH, CORT concentration;Changes in intestinal microbial composition); | — |
Countries
China
Contacts
Public ContactHui-rong Liu
Shanghai Research Institute of Acupuncture and Meridian
Outcome results
None listed