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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Tong-Xie-Yao-Fang intervention groupExperimental treatment 1 intervention
Group B: healthy peopleNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Fecal metagenomic detection of bacteria associated with Trp metabolism

Time frame
16weeks
2

Serum detection by Elisa

Time frame
16weeks
3

Serum Trp metabolism was measured by metabolomics

Time frame
16weeks
4

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

Time frame
16weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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