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

NCT06737666 | Recruiting Phase 1 DMC

• 1 other identifier: 2022XLA162-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (5)

• Fecal metagenomic detection of bacteria associated with Trp metabolism

  16weeks

• Serum detection by Elisa

  16weeks

• Serum Trp metabolism was measured by metabolomics

  16weeks

• Th17/Treg ratio in peripheral blood was measured by flow cytometry

  16weeks

• Colon tissue was detected by immunofluorescence and histochemistry analysis

  Foxp3 ,RORrt ,AhR ,IDO1 ,Tyn

  16weeks

Study Arms (2)

Tong-Xie-Yao-Fang intervention group

EXPERIMENTAL

Drug: Tong-Xie-Yao-Fang

healthy people

NO INTERVENTION

Interventions

Tong-Xie-Yao-Fang DRUG

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

Tong-Xie-Yao-Fang intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

Central Study Contacts

Fengyun Wang, professor

CONTACT

+86 (010)-62835610; wfy811@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: December 17, 2024
• Study Start: May 29, 2023
• Primary Completion: October 8, 2025
• Study Completion: December 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

CN (1)