Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Clinical study on the treatment of diarrheal irritable bowel syndrome with liver-stagnation and spleen-deficiency syndrome by acupuncture and moxibustion

Registration number：

ITMCTR2025000547

Date of Last Refreshed on：

2025-03-18

Date of Registration：

2025-03-18

Registration Status：

Prospective registration

Public title：

Clinical study on the treatment of diarrheal irritable bowel syndrome with liver-stagnation and spleen-deficiency syndrome by acupuncture and moxibustion

English Acronym：

Scientific title：

Clinical study on the treatment of diarrheal irritable bowel syndrome with liver-stagnation and spleen-deficiency syndrome by acupuncture and moxibustion

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Qingyu Song

Study leader：

Yin Shi

Applicant telephone：

15265491221

Study leader's telephone：

13816042916

Applicant Fax：

Study leader's fax：

Applicant E-mail：

txzzsqy@163.com

Study leader's E-mail：

flysy0636@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

358 Datong Road Gaoqiao Town Pudong New Area Shanghai

Study leader's address：

358 Datong Road Gaoqiao Town Pudong New Area Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shanghai Seventh People's Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2025-7th-HIRB-017

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Shanghai Seventh People's Hospital

Date of approved by ethic committee：

2025/1/24 0:00:00

Contact Name of the ethic committee：

Chunyan Zhang

Contact Address of the ethic committee：

Shanghai Seventh People's Hospital

Contact phone of the ethic committee：

021-58670561-6659/6449

Contact email of the ethic committee：

qiyuanlunli@163.com

Primary sponsor：

Shanghai Seventh People's Hospital

Primary sponsor's address：

358 Datong Road Gaoqiao Town Pudong New Area Shanghai

Secondary sponsor：

Country：

People's Republic of China

Province：

Shanghai Municipality

City：

Institution
hospital：

Shanghai Seventh People's Hospital

Address：

358 Datong Road Gaoqiao Town Pudong New Area Shanghai

Source(s) of funding：

Shanghai Pudong New Area Health Commission

Target disease：

Diarrheal irritable bowel syndrome

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

Aiming at the diarrhea IBS patients with the most common clinical syndrome of liver-Qi and spleen-deficiency we proposed "warming the spleen and stomach and regulating the fu-qi and blood" as the treatment method adopted moxibustion at Zhongwan Qihai and Tianshu points to warm the spleen and stomach and acupuncture at Hegu Taichong Zusanli and Shangjuxu points to regulate the fu-qi and blood and observed the clinical curative effect of acupuncture and moxibustion treatment and its influence on intestinal flora and bile acid metabolism. In order to demonstrate the efficacy and safety of acupuncture and moxibustion for warming the spleen and stomach and thinning the fu-qi and blood in the treatment of diarrheal IBS with liver-stagnation and spleen-deficiency syndrome and initially explain the regulatory mechanism of intestinal microbiota and bile acid metabolism in patients with diarrheal IBS with liver-stagnation and spleen-deficiency syndrome.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Patients with diarrheal IBS who meet the diagnostic criteria; (2) TCM syndrome differentiation belongs to liver depression and spleen deficiency syndrome; (3) Age between 18 and 65 years old gender is not limited; (4) Inspection indicators: the general situation is good; Blood urine stool routine (-) bacterial culture (-) fecal occult blood (-); Liver and kidney function and blood sugar were normal abdominal B was abnormal. Thyroid function was normal. Colonoscopy showed no morphological or histological abnormalities. (5) Sign the patient's informed consent voluntarily.

Exclusion criteria：

(1) Patients with organic intestinal lesions; (2) Patients with other types of IBS; (3) Simultaneous use of drugs that affect the efficacy evaluation of this study (such as Smecta desutes Cisapride or traditional Chinese medicine etc.) Of patients; (4) Suffering from other organic diseases of the digestive system tumors confirmed by colonoscopy or barium enema inflammatory bowel disease intestinal tuberculosis or other organic diseases or suffering from systemic diseases causing diarrhea such as lactase deficiency hyperthyroidism etc.; (5) with fever anemia blood in the stool or serious heart liver kidney endocrine and metabolic disorders hematopoietic system disorders malignant tumors or mental disorders and other diseases in the acute stage; (6) Pregnant or lactating women; (7) There are scars or sensory disorders in the body surface area of the acupuncture points involved in this study resulting in the inability to perform acupuncture.

Study execute time：

From 2025-01-01

To      2027-12-31

Recruiting time：

From 2025-05-01

To      2027-03-31

Interventions：

31

Group：

Sham acupuncture group

Sample size：

Intervention：

False isolation moxibustion combined with false acupuncture

Intervention code：

31

Group：

Acupuncture and moxibustion group

Sample size：

Intervention：

Isolated moxibustion combined with acupuncture

Intervention code：

Total sample size ： 62

Countries of recruitment
and research settings：

Country：

People's Republic of China

Province：

Shanghai Municipality

City：

Institution/hospital：

Shanghai Seventh People's Hospital

Level of the institution：

Third class first class

Outcomes：

Outcome：

Cholesterol 7 α-hydroxylase

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-Rating Depression Scale (SDS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Irritable Bowel Syndrome Severity Scale (IBS-SSS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Irritable Bowel Syndrome Gastrointestinal Symptom Scale (GSRS-IBS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

7 alpha-hydroxy-4-cholesterene-3-one

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-Rating Anxiety Scale (SAS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Numerical Evaluation Scale for Abdominal Pain (NRS)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Total bile acids

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Deoxycholic acid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Cholic acid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Effective Response Rate (ERR)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IBS Quality of Life Scale (IBS-QOL)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Bristol symptom score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM syndrome score scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Safety evaluation

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Intestinal flora

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Lithocholic acid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Stool

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The method of complete random grouping was adopted. The random numbers are generated by SPSS software and read in the order from left to right and from top to bottom recorded on random cards and sealed in envelopes without any marks on the envelopes which are kept by special personnel. When qualified subjects enter the study an envelope will be randomly selected and the treatment plan will be allocated according to the parity of the card numbers in which odd numbers will enter the fake acupuncture group. Even numbers entered the acupuncture group.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

no

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

There is a special person to fill in the case report form and the assessment of symptoms should be objective and specific; The relevant data shall be entered and properly stored by special personnel.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above