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

Study Overview
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Brief Summary
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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.

Official Title
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Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases

Conditions
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Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: tong-jiang granules
* Drug: Chang 'an II Recipe
* Drug: The placebo of tong-jiang granules
* Drug: The placebo of Chang 'an II Recipe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with no abnormal clinical manifestations; Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency. Aged between 18 and 70. 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; Subjects are informed and sign informed consent voluntarily; Have certain reading ability. Exclusion Criteria: Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases; 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); Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.); Those with a history of allergy to related drugs or severe food allergy used in the research. The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-erosive reflux disease test group<br> | Drug: tong-jiang granules<br>* This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.<br>|
| Placebo Comparator: Non-erosive reflux disease control group<br> | Drug: The placebo of tong-jiang granules<br>* This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.<br>|
| Experimental: Diarrhea-type irritable bowel syndrome test group<br> | Drug: Chang 'an II Recipe<br>* This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.<br>|
| Placebo Comparator: Control group with diarrheal irritable bowel syndrome<br> | Drug: The placebo of Chang 'an II Recipe<br>* This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.<br>|
| No Intervention: Healthy control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 7 point Likert scale scores | The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) (1 point for obvious improvement of symptoms, 2 points for improvement of symptoms, 3 points for slight improvement of symptoms, 4 points for no change, 5 points for slight aggravation of symptoms, 6 points for aggravation of symptoms, and 7 points for obvious aggravation of symptoms) | Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period | 
| Changes in irritable bowel syndrome symptom severity scale scores | Irritable bowel syndrome symptom severity scale scores were assessed before and after treatment and during follow-up. The scoring standard is the same as the international standard. | Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period |