Efficacy and Safety of Modified Gegen Qinlian Decoction for Diarrhea-predominant Irritable Boewl Syndrome
Primary Purpose
Diarrhea-predominant Irritable Boewl Syndrome
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Modified Gegen Qinlian Decoction
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea-predominant Irritable Boewl Syndrome
Eligibility Criteria
Inclusion Criteria:
- It meets the diagnostic criteria of diarrhea-predominant irritable boewl syndrome and meets the diagnostic criteria for damp-heat syndrome.
- Age between 18 and 70 years old.
- Not taking antibiotics, steroids and other hormones, Chinese herbal preparations in the past week (including) Probiotics such as oral and intravenous), microecological preparations or yogurt.
- The subject informed and voluntarily signed the informed consent form. ;
- Have a certain reading ability
Exclusion Criteria:
- Patients with severe organ, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental illness;
- combined with other digestive systemic lesions (such as peptic ulcer), or systemic diseases affecting digestive tract motility (eg hyperthyroidism, diabetes);
- Those who are or need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anxiolytics, intestinal flora regulators, antibiotics, etc.);
- Those with a history of allergic reactions to related drugs and a history of severe food allergies.
Sites / Locations
- XiyuanhospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Modified Gegen Qinlian Decoction, Oral, 7.2g per bag, 2 times / day, 30 minutes before breakfast and dinner
Bifico(Bifidobacterium triple viable capsule), orally,2 capsules/time, 2 days/time.
Outcomes
Primary Outcome Measures
IBS symptom severity (IBS-SSS)scale
The IBS-SSS scale is scored from five aspects: the degree of abdominal pain, the frequency of abdominal pain, the degree of bloating, the degree of defecation satisfaction, and the impact on life.Each score is 0-100 points, and the total score is IBS-SSS scores from the degree of abdominal pain, the frequency of abdominal pain, the degree of abdominal distention, the satisfaction of defecation and the impact on life. Each score is 0-100, and the total score is 0-500. The higher the score, the more serious the disease is.
The Clinical Global Impression of severity Scale ( CGI-S)
Secondary Outcome Measures
Bristol Stool Form Scale
PRO scale
The short form 36 (SF-36) health survey questionnaire
The scores of TCM(Traditional Chinese Medicine) syndrome
Full Information
NCT ID
NCT04312477
First Posted
January 15, 2020
Last Updated
March 13, 2020
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04312477
Brief Title
Efficacy and Safety of Modified Gegen Qinlian Decoction for Diarrhea-predominant Irritable Boewl Syndrome
Official Title
The Correlation Within Diarrhea-predominant Irritable Boewl Syndrome(IBS-D) and Intestinal Microbiota Via C1orf106/Cytohesin-1(CYTH-1) /Adenosine Diphosphate-ribosylation Factor 6(ARF6) Signal Pathway and the Intervention Mechanism of Classic Chinese Compound Formula With Clearing Heat and Promoting Dieresis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
December 31, 2023 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diarrhea-predominant irritable boewl syndrome(IBS-D) seriously affect the quality of life in patients. Clinically, it is effective to apply therapeutic method of clearing heat and promoting diuresis to the common syndrome of dampness-heat. Dysbiosis of intestinal microbiota is closely related to the immune imbalance and intestinal mucosal barrier injury. C1orf106/CYTH-1/ARF6 signal pathway, which derive from intestinal micro environment changes,is the mainly cause of intestinal mucosal barrier injury, and this is may be the common pathogenesis of dampness-heat syndrome in IBS-D . Based on the clinic, the project is to study the effect and mechanism of Chinese compound formula of clearing heat and promoting dieresis in modulating intestinal microbiota dysbiosis, repairing intestinal mucosal barrier and reconstructing intestinal microenvironment. With the combination of metagenomics and metabonomics, the study compare the differences of co-metabolites of intestinal microbiota and host within the healthy people, IBS-D patients with dampness-heat syndrome, to explore the relevance between intestinal flora and host co-metabolites. Furthermore, the experimental study is to clarify the drug targets via C1orf106/ CYTH-1/ARF6 signal pathway.Through the study of association between dampness-heat syndrome in IBS-D and intestinal microbiota, it is of important academic significance to reveal the Chinese theory intension of "homotherapy for heteropathy ".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea-predominant Irritable Boewl Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Modified Gegen Qinlian Decoction, Oral, 7.2g per bag, 2 times / day, 30 minutes before breakfast and dinner
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Bifico(Bifidobacterium triple viable capsule), orally,2 capsules/time, 2 days/time.
Intervention Type
Drug
Intervention Name(s)
Modified Gegen Qinlian Decoction
Intervention Description
Modified Gegen Qinlian Decoction contains Pueraria lobata 24g, Scutellaria baicalensis 9g, Coptis chinensis 9g, artillery ginger 9g, talc 9g, roasted licorice 6g, and granules are prepared according to 10:1 production process.
Primary Outcome Measure Information:
Title
IBS symptom severity (IBS-SSS)scale
Description
The IBS-SSS scale is scored from five aspects: the degree of abdominal pain, the frequency of abdominal pain, the degree of bloating, the degree of defecation satisfaction, and the impact on life.Each score is 0-100 points, and the total score is IBS-SSS scores from the degree of abdominal pain, the frequency of abdominal pain, the degree of abdominal distention, the satisfaction of defecation and the impact on life. Each score is 0-100, and the total score is 0-500. The higher the score, the more serious the disease is.
Time Frame
Change from Baseline disease activity at 4weeks
Title
The Clinical Global Impression of severity Scale ( CGI-S)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Bristol Stool Form Scale
Time Frame
4 weeks
Title
PRO scale
Time Frame
4 weeks
Title
The short form 36 (SF-36) health survey questionnaire
Time Frame
4 weeks
Title
The scores of TCM(Traditional Chinese Medicine) syndrome
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
It meets the diagnostic criteria of diarrhea-predominant irritable boewl syndrome and meets the diagnostic criteria for damp-heat syndrome.
Age between 18 and 70 years old.
Not taking antibiotics, steroids and other hormones, Chinese herbal preparations in the past week (including) Probiotics such as oral and intravenous), microecological preparations or yogurt.
The subject informed and voluntarily signed the informed consent form. ;
Have a certain reading ability
Exclusion Criteria:
Patients with severe organ, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental illness;
combined with other digestive systemic lesions (such as peptic ulcer), or systemic diseases affecting digestive tract motility (eg hyperthyroidism, diabetes);
Those who are or need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anxiolytics, intestinal flora regulators, antibiotics, etc.);
Those with a history of allergic reactions to related drugs and a history of severe food allergies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaqi Zhang, MD
Phone
+8615210595175
Email
zjq405@163.com
Facility Information:
Facility Name
Xiyuanhospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqi Zhang, MD
Phone
+8615210595175
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Modified Gegen Qinlian Decoction for Diarrhea-predominant Irritable Boewl Syndrome
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