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

Phase 4

• Conditions: Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome
• Interventions: Drug: The placebo of Chang 'an II Recipe; Drug: The placebo of tong-jiang granules; Drug: Chang 'an II Recipe; Drug: tong-jiang granules

• Registration Number: NCT04454996
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-20
• Study Start: 2020-06-25
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02
• Primary Completion: 2021-09-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group with diarrheal irritable bowel syndrome	The placebo of Chang 'an II Recipe	-
Non-erosive reflux disease control group	The placebo of tong-jiang granules	-
Diarrhea-type irritable bowel syndrome test group	Chang 'an II Recipe	-
Non-erosive reflux disease test group	tong-jiang granules	-

Primary Outcome Measures

Name	Time	Method
Changes in 7 point Likert scale scores	Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period	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)
Changes in irritable bowel syndrome symptom severity scale scores	Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period	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.

Trial Locations

Locations (1)

Xiyuan Hospital of China Academy of Chinese Medical Science; 🇨🇳 Beijing, Beijing, China