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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-erosive reflux disease test group | Experimental |
| |
| Non-erosive reflux disease control group | Placebo Comparator |
| |
| Diarrhea-type irritable bowel syndrome test group | Experimental |
| |
| Control group with diarrheal irritable bowel syndrome | Placebo Comparator |
| |
| Healthy control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tong-jiang granules | Drug | This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks. |
|
| 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 |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lin lv | Contact | 18811782728 | lushangshitou@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Science | Recruiting | Beijing | Beijing Municipality | 100091 | China |
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| Chang 'an II Recipe | Drug | This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks. |
|
| The placebo of tong-jiang granules | Drug | This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks. |
|
| The placebo of Chang 'an II Recipe | Drug | This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks. |
|
| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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