Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome

Treatments: Drug: The placebo of Chang 'an II Recipe; Drug: Chang 'an II Recipe; Drug: tong-jiang granules; Drug: The placebo of tong-jiang granules

Study type: Interventional

Funder types: Other

Identifiers

NCT04454996

ZZ13-ZD-02

Details and patient eligibility

About

To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy volunteers with no abnormal clinical manifestations;
2. Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.
3. Aged between 18 and 70.
4. Did not take antibiotics, steroids or other hormones, Chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week;
5. Subjects are informed and sign informed consent voluntarily;
6. Have certain reading ability.

Exclusion criteria

1. Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;

2. Complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes);

3. Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);

4. Those with a history of allergy to related drugs or severe food allergy used in the research.

5. The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 5 patient groups, including a placebo group

Non-erosive reflux disease test group

Experimental group

Treatment:

Drug: tong-jiang granules

Non-erosive reflux disease control group

Placebo Comparator group

Treatment:

Drug: The placebo of tong-jiang granules

Diarrhea-type irritable bowel syndrome test group

Experimental group

Treatment:

Drug: Chang 'an II Recipe

Control group with diarrheal irritable bowel syndrome

Placebo Comparator group

Treatment:

Drug: The placebo of Chang 'an II Recipe

Healthy control group

No Intervention group