Diarrheal irritable bowel syndrome
Conditions
Interventions
Healthy Female Control Group:None
Sham Warm Moxibustion Group:Refined 3-cm moxa sticks were used to apply moxibustion at Zhongwan (CV12), bilateral Tianshu (ST25), Shangjuxu (ST37), and Sanyinjiao (SP6). The sticks were held 8–10 cm a
Taiyi Warm Moxibustion Group:Refined 3-cm moxa sticks were used to apply moxibustion at Zhongwan (CV12), bilateral Tianshu (ST25), Shangjuxu (ST37), and Sanyinjiao (SP6). The sticks were held 3–5 cm a
Sponsors
Shanghai Research Institute of Acupuncture and Meridian
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Female IBS-D Participants (1)Meet the diagnostic criteria for IBS-D as defined by the Rome IV criteria and the 2020 Chinese Expert Consensus on Irritable Bowel Syndrome. (2)Female aged 18 to 49 years. (3)Weekly abdominal pain score = 3 (on a 0-10 scale). (4)Understand and agree to participate in the study and sign the informed consent form. Inclusion Criteria for Healthy Female Participants (1)No abdominal pain bloating abdominal discomfort or changes in stool form and frequency in the past 6 months. (2)Female aged 18 to 49 years. (3)Understand and agree to participate in the study and sign the informed consent form. Inclusion Criteria for Male IBS-D Participants (1)Meet the diagnostic criteria for IBS-D as defined by the Rome IV criteria and the 2020 Chinese Expert Consensus on Irritable Bowel Syndrome. (2)Male aged 18 to 49 years. (3)Weekly abdominal pain score = 3 (on a 0-10 scale). (4)Understand and agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Female IBS-D Participants (1)Presence of organic intestinal diseases or post-infectious IBS-D. (2)Age > 40 years with irregular menstrual cycles for over 6 months; or age = 40 years with irregular menstrual cycles for over 1 year; or patients with gynecological organic diseases. (3)Patients with severe cardiovascular cerebrovascular hepatic renal diseases or malignant tumors. (4)Patients with psychiatric disorders or moderate to severe anxiety and depression. (5)Patients with a history of gastrointestinal surgery above grade 2 or gastrointestinal resection. (6)Patients who have used medications for IBS-D within 2 months prior to enrollment. (7)Patients who have participated in or are currently participating in other clinical trials within 1 month prior to enrollment. (8)Patients with skin diseases limb defects or other conditions in the acupoint areas selected for this study that prevent moxibustion treatment. (9)Patients with a history of warm moxibustion therapy. (10)Pregnant or lactating patients. (11)Patients who have taken any medications (e.g. probiotics lactic acid bacteria beverages antidiarrheals gastrointestinal motility drugs antibiotics traditional Chinese medicine etc.) that may affect the study's outcome measures within the past 3 months. Exclusion Criteria for Healthy Female Participants (1)Participants with contraindications for brain neuroimaging. (2)Participants with organic intestinal diseases or a history of gastrointestinal surgery above grade 2 or gastrointestinal resection. (3)Age > 40 years with irregular menstrual cycles for over 6 months; or age = 40 years with irregular menstrual cycles for over 1 year; patients with a history of hysterectomy or bilateral salpingo-oophorectomy; or patients with gynecological organic diseases. (4)Participants with severe cardiovascular cerebrovascular hepatic renal diseases or malignant tumors. (5)Participants with psychiatric disorders or moderate to severe anxiety and depression. (6)Participants who have participated in or are currently participating in other clinical trials within 1 month prior to enrollment. (7)Pregnant or lactating participants. (8)Participants who have consumed any foods or medications (e.g. probiotics lactic acid bacteria beverages antidiarrheals gastrointestinal motility drugs antibiotics traditional Chinese medicine etc.) that may affect the study's outcome measures within the past 3 months. Exclusion Criteria for Male IBS-D Participants (1)Patients with contraindications for brain neuroimaging. (2)Patients with organic intestinal diseases or post-infectious IBS-D. (3)Patients with severe cardiovascular cerebrovascular hepatic renal diseases or malignant tumors. (4)Patients with psychiatric disorders or moderate to severe anxiety and depression. (5)Patients with a history of gastrointestinal surgery above grade 2 or gastrointestinal resection. (6)Patients who have used medications for IBS-D within 2 months prior to enrollment. (7)Patients who have participated in or are currently participating in other clinical trials within 1 month prior to enrollment. (8)Patients who have consumed any foods or medications (e.g. probiotics lactic acid bacteria beverages antidiarrheals gastrointestinal motility drugs antibiotics traditional Chinese medicine etc.) that may affect the study's outcome measures within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive Response Rate at Week 6 of Intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comprehensive Response Rate at Week 12 of Intervention;Emotional status Assessment (Hospital Anxiety and Depress Scale);Comparison of repeated measurements of comprehensive response rates at weeks 3 6 9 and 12;Safety Assessment;IBS quality of life;Visual Analogue Scale;IBS symptom severity scale; | — |
Countries
China
Contacts
Public ContactFang Zhang
Shanghai Research Institute of Acupuncture and Meridian
Outcome results
None listed