Back to resultsStudy on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen
Primary Purpose
Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tong-jiang granules
Chang 'an II Recipe
The placebo of tong-jiang granules
The placebo of Chang 'an II Recipe
Sponsored by
About this trial
This is an interventional treatment trial for Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome
Eligibility Criteria
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.
-
Sites / Locations
- Xiyuan Hospital of China Academy of Chinese Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
No Intervention
Arm Label
Non-erosive reflux disease test group
Non-erosive reflux disease control group
Diarrhea-type irritable bowel syndrome test group
Control group with diarrheal irritable bowel syndrome
Healthy control group
Arm Description
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04454996
First Posted
June 20, 2020
Last Updated
June 30, 2020
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04454996
Brief Title
Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen
Official Title
Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2020 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-erosive reflux disease test group
Arm Type
Experimental
Arm Title
Non-erosive reflux disease control group
Arm Type
Placebo Comparator
Arm Title
Diarrhea-type irritable bowel syndrome test group
Arm Type
Experimental
Arm Title
Control group with diarrheal irritable bowel syndrome
Arm Type
Placebo Comparator
Arm Title
Healthy control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
tong-jiang granules
Intervention Description
This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Chang 'an II Recipe
Intervention Description
This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
The placebo of tong-jiang granules
Intervention Description
This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
The placebo of Chang 'an II Recipe
Intervention Description
This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.
Primary Outcome Measure Information:
Title
Changes in 7 point Likert scale scores
Description
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)
Time Frame
Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
Title
Changes in irritable bowel syndrome symptom severity scale scores
Description
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.
Time Frame
Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lin lv
Phone
18811782728
Email
lushangshitou@qq.com
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lin lv
Phone
18811782728
Email
lushangshitou@qq.com
12. IPD Sharing Statement
Learn more about this trial
Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen
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