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Efficacy and safety of mild moxibustion in the treatment of diarrhea-predominant irritable bowel syndrome (spleen deficiency and dampness excess syndrome): A study protocol for a randomized controlled trial

Efficacy and safety of mild moxibustion in the treatment of diarrhea-predominant irritable bowel syndrome (spleen deficiency and dampness excess syndrome): A study protocol for a randomized controlled trial

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230523002
Enrollment
92
Registered
2023-05-23
Start date
2023-06-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Based on TCM theory, weakness of the spleen and stomach is the main cause of IBS-D, and spleen deficiency and dampness excess syndrome is a common type in clinical practice[16,17]. The therapeutic effect of moxibustion is mainly derived from the thermal effect of moxa burning on acupoints of body surface[18] and the chemical stimulation of drug components in moxa leaves[19,20], which can achieve the effect of invigorating spleen and dispelling dampness. Mild moxibustion is a complementary altern

Interventions

Patients were placed in supine position, and moxa strips were placed on the moxibustion racks with the burning end of the moxa strips perpendicular to the acupoints and 3 to 5cm from the acupoints, to
Experimental Other
moxa strips

Sponsors

Lijiang Ji
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients should meet both TCM and Western diagnostic criteria of IBS-D; 2.Patients at age of 18 to 65 years old; 3.No history of relevant treatment before enrollment or with discontinuation of treatment with Chinese medicine, antidiarrheal drugs and antispasmodics for more than 1 month; 4.The total score of the IBS Severity Scoring System score(IBS-SSS) is more than 75; 5.Voluntary participation in this study and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with IBS-C, IBS-M, and IBS-U; 2.Patients with inflammatory bowel disease, organic intestinal lesions, peptic ulcer, infectious diarrhea; 3.Patients combined with severe cardiovascular, hepatic, renal, endocrine and hematopoietic system diseases; patients with other diseases other than diarrhea that may affect the test results that cannot be discontinued; patients with mental illness; 4.Patients who are pregnant or lactating, and those who have a birth plan from their enrollment to 1 month after the end of the trial; 5.Those who have participated in other clinical trials within 1 month.

Design outcomes

Primary

MeasureTime frame
IBS-SSS 8 weeks includes five aspects with a score range of 0 to 100 out of 500 for each indicator

Secondary

MeasureTime frame
Irritable Bowel Syndrome-Quality of Life(IBS-QOL)score 8 weeks The score of Irritable Bowel Syndrome-Quality of Life

Countries

China

Contacts

Public ContactYunyi Chen

Changshu Hospital Affiliated to Nanjing University of  Chinese Medicine

18550323273@163.com19932602475

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026