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Study on the Effectiveness and Mechanism of Tong-Xie-Yao-Fang in Treating Diarrhea-predominant Irritable Bowel Syndrome

NCT ID: NCT06737666

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-29

Study Completion Date

2025-12-31

Brief Summary

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Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen to treat on Diarrhea-predominant irritable bowel syndrome (IBS-D) . The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF). Based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.

Detailed Description

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Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common clinical functional gastrointestinal disease with unclear mechanism, which is mostly induced by emotion. There is no specific treatment for this disease. Traditional Chinese Medicine focuses on the main pathogenesis of liver depression and spleen deficiency, and treats them from the perspective of soothing the liver and strengthening the spleen. The classic formula for treating is the Tong-Xie-Yao-Fang (TXYF).Previous studies of our research group have shown that TXYF can significantly improve the symptoms of abdominal pain and diarrhea in patients with IBS-D, and improve the quality of life of patients. The effectiveness and safety of TXYF in the treatment of IBS-D have been evaluated, and its mechanism of action has also been explored.Modern studies have shown that changes in the local immune microenvironment can affect intestinal immunity and neuroregulation, mucosal barrier damage and abnormal co-metabolism of flora and host, which may be important reasons for the occurrence and development of IBS-D, but the detailed mechanism is unclear.Therefore, based on metabolomics and metagenomics, the research group studied the intestinal flora and host co metabolism of TXYF in the treatment of diarrhea predominant IBS-D, in order to clarify the mechanism of TXYF in the treatment of IBS-D.

Conditions

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Diarrhea-predominant Irritable Bowel Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tong-Xie-Yao-Fang intervention group

Group Type EXPERIMENTAL

Tong-Xie-Yao-Fang

Intervention Type DRUG

Tong-Xie-Yao-Fang granules were taken 2 bags at a time, 2 times per day at 1h after meal for 4 weeks.

healthy people

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tong-Xie-Yao-Fang

Tong-Xie-Yao-Fang granules were taken 2 bags at a time, 2 times per day at 1h after meal for 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* IBS-D patients and healthy volunteers meeting diagnostic criteria;
* Aged between 18 and 70;
* Have not taken antibiotics, steroids and other hormones, Chinese herbal preparations (including oral and intravenous injections), microecological preparations or probiotics such as yogurt in the past week.
* Patients sign informed consent forms and are willing to receive appropriate treatment, and volunteers are willing to cooperate in taking blood, urine, stool and other samples.

Exclusion Criteria

* Patients with serious heart, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental diseases;
* Other organic diseases of the digestive system (such as peptic ulcers), organic diseases such as tumors indicated by recent colonoscopy, or systemic diseases affecting digestive motility (such as hyperthyroidism, diabetes);
* Need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anti-anxiety drugs, intestinal flora regulation drugs, antibiotics, etc.);
* Have a history of drug allergy or severe food allergy for research purposes;
* Patients under 18 years of age or over 75 years of age and pregnant or lactating women;
* Severe negative life events occurred during treatment;
* There is currently any form of psychotherapy in progress;
* No intention to cooperate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fengyun Wang, professor

Role: CONTACT

Phone: +86 (010)-62835610

Email: [email protected]

Facility Contacts

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Fengyun Wang, professor

Role: primary

Other Identifiers

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2022XLA162-3

Identifier Type: -

Identifier Source: org_study_id