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Regulating Intestines and Calming Acupuncture Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: a Randomized Clinical Trial and fMRI Study

Regulating Intestines and Calming Acupuncture Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: a Randomized Clinical Trial and fMRI Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078682
Enrollment
Unknown
Registered
2023-12-15
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome with predominant Diarrhea

Interventions

Regulating intestines and calming acupuncture group:The acupoints are ST25, RN12, RN6, ST36, ST37, DU20, EX-HN3, LR3. The acupuncture location and acupuncturist's hand should be strictly disinfected w
Regulating intestines and calming acupuncture group:The acupoints are ST25, RN12, RN6, ST36, ST37, and two non-acupoints(four points). The acupuncture location and acupuncturist's hand should be stric
Sham acupuncture group:In this group, six non-acupoints(twelve points) are chonsen. Paste the disposable sterile foam pad on the non-acupoint, insert the disposable sterile blunt-tipped acupuncture in

Sponsors

Dongzhimen Hosipital Affilliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: IBS-D inclusion criteria ? Between the ages of 18 and 49 (including 18 and 49 years old), male and female; ? It meets the diagnostic criteria of Rome IV IBS-D; ?In the past 2 weeks, daily defecation diaries reported Bristol fecal trait type 6 or 7 for at least 4 days and Bristol fecal trait type 1 or 2 for less than 4 days; The average daily abdominal pain score in recent 1 week was =3 points; ? have not received acupuncture treatment in the past 6 months; ?No antidepressants or drugs that have therapeutic effects on IBS symptoms within 2 weeks before treatment, including traditional Chinese medicines or proprietary Chinese medicines, antidiarrhea agents, spasmodic drugs, intestinal antibiotics, probiotics, etc.; ? Right-handed. HC inclusion creteria ? Between the ages of 18 and 49 (including 18 and 49 years old), male and female; ?18-49(1849),; ?No digestive and gastrointestinal diseases, no brain trauma, drug and alcohol dependence and diseases that may affect brain structure and function; ? No serious acute/chronic organic diseases; ? All the daily defecation diary reports in the past week were Bristol fecal traits type 3 or type 4; ?Have not received acupuncture treatment in the past 6 months; ? No history of drug use in the past 2 weeks, including traditional Chinese medicine or proprietary Chinese medicine, antidiarrhea, spasmolytic, intestinal antibiotics, probiotics, etc.; ? Right-handed.

Exclusion criteria

Exclusion criteria: ?A history of inflammatory bowel disease/microscopic colitis/celiac disease/Crohn's disease and other organic bowel diseases, and the presence of the following warning symptoms: unexplained weight loss (=10% weight loss within 3 months), nocturnal diarrhea, blood in the stool not caused by hemorrhoids or anal fusing, family history of colorectal cancer should provide colonoscopy results within 2 years; ? Severe acute/chronic organic diseases; ? Difficulties in participating in the trial, such as serious mental illness, dementia or illiteracy; (4) Previous history of abdominal surgery (appendix surgery, hemorrhoid surgery, polyp surgery more than 3 months can be included); (5) Pregnant women, women of childbearing age who have not used contraceptives, women during pregnancy and breastfeeding; 6. Suspected or have a history of alcohol or drug abuse; 7. Magnetic resonance examination contraindications: patients with cardiac pacemakers, nerve stimulators, artificial metal heart valves, etc.; Those with aneurysm clips (except non-paramagnetic alloys); Metal foreign bodies, inner ear implants, metal prostheses, metal prostheses, metal joints, and ferromagnetic foreign bodies in the body; Patients with severe hyperthermia.

Design outcomes

Primary

MeasureTime frame
Effective response rate of week-4;

Secondary

MeasureTime frame
Effective response rate at other time points;IBS symptom severity scale, IBS-SSS;Quality of life questionnaire, IBS-QOL;Generalized Anxiety Disorder, GAD-7;Patient Health Questionnaire-9, PHQ-9;IBS Adequate Relief, IBS-AR;Defecation frequency;Symptoms of abdominal pain;Symptoms of bloating;Blind method and credibility evaluation;Adverse event rate;

Countries

China

Contacts

Public ContactCunzhi, Liu

Dongzhimen Hosipital Affilliated to Beijing University of Chinese Medicine

lcz_tg@126.com+86 10 5391 2201

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026