Back to resultsMechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang
Primary Purpose
IBS (Irritable Bowel Syndrome)
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tongxieyaofang(granule)
Sponsored by
About this trial
This is an interventional basic science trial for IBS (Irritable Bowel Syndrome) focused on measuring IBS-D
Eligibility Criteria
Inclusion Criteria:
- Patients meeting the diagnostic criteria of Western medicine for IBS-D;
- aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
- voluntarily signed the informed consent;
- local resident who could ensure follow-ups, with basic reading ability
Exclusion Criteria:
- Patients with IBS-C, -M, and uncertain forms;
- accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
- gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism,diabetes, chronic renal insufficiency, and nervous system diseases);
- undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
- with history of abdominal surgery (e.g., cholecystectomy);
- with an allergy history of tested drugs or severe allergy history of food;
- pregnant and lactating female;
- with a history of neurological or psychiatric disorders;
- or participating in other clinical trial.
Sites / Locations
- Xiyuan hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
health control group
Tongxieyaofang granule group
Arm Description
Outcomes
Primary Outcome Measures
Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale
Patients are graded according to their own symptoms（abdominal pain，bloating，defecation satisfaction，the extent to which the disease affects the lives of patients，bowel movements）, the total score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe. We will assess changes in patient scores before and after treatment to reflect the extent of disease remission.
Bristol stool form scale（BSFS）
Different fecal types can reflect different intestinal transit times, the lower the score, the longer the transmission time; the higher the score, the shorter the transmission time. We will assess changes in scores before and after treatment to reflect the extent of disease remission.
Secondary Outcome Measures
IBS-D PRO( patient reported outcomes) Scale
Grading from the field of physiology, independence, and psychology，Use score changes to assess improvement in all areas of the patient.Minimum score is 0，means no symptoms，maximum score is 144，means all symptoms are severe.
SF-36(the MOS item short from health survey)Scale
Score evaluation from 8 aspects: physical function, role-physical, pain, global health status, vitality，social function,role-emotional， mental health.Use score changes to assess improvement in all areas of the patient. Maximum score is147.The higher the score, the better the status in all aspects.
Full Information
NCT ID
NCT04122586
First Posted
September 25, 2019
Last Updated
December 29, 2019
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04122586
Brief Title
Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang
Official Title
Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients " of Tongxieyaofang
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (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 irritable bowel syndrome(IBS-D）has seriously affected health and quality of life of patients.It may be important pathogenesis in development and recurrence of the process of IBS-D,excessive endoplasmic reticulum stress (ERS) activated PERK(proteinkinaseR-like ERkinase，PERK)-eIF2a(eukaryotic translation initiation factor 2 alpha,eIF2a) pathway and damaged intestinal mucosal epithelial Barrier. Tongxieyaofang(TXYF) had obtained satisfactory effect in treating IBS-D in clinic and previous study, but it is unknown that herbal formula how to work.This project applies metabolomics method to detect plasma,urine and stool metabolites for patients before and after treatment, to determine the effects of the"multiple ingredients"of TXYF in body.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS (Irritable Bowel Syndrome)
Keywords
IBS-D
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
health control group
Arm Type
No Intervention
Arm Title
Tongxieyaofang granule group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tongxieyaofang(granule)
Intervention Description
Take this granule twice a day,one bag for each time,one hour after a meal,for 4 weeks
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale
Description
Patients are graded according to their own symptoms（abdominal pain，bloating，defecation satisfaction，the extent to which the disease affects the lives of patients，bowel movements）, the total score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe. We will assess changes in patient scores before and after treatment to reflect the extent of disease remission.
Time Frame
IBS-SSS was evaluated by patients at 4th week
Title
Bristol stool form scale（BSFS）
Description
Different fecal types can reflect different intestinal transit times, the lower the score, the longer the transmission time; the higher the score, the shorter the transmission time. We will assess changes in scores before and after treatment to reflect the extent of disease remission.
Time Frame
BSFS was evaluated by patients at 4th week
Secondary Outcome Measure Information:
Title
IBS-D PRO( patient reported outcomes) Scale
Description
Grading from the field of physiology, independence, and psychology，Use score changes to assess improvement in all areas of the patient.Minimum score is 0，means no symptoms，maximum score is 144，means all symptoms are severe.
Time Frame
IBS-D PRO Scale was evaluated at 4th week
Title
SF-36(the MOS item short from health survey)Scale
Description
Score evaluation from 8 aspects: physical function, role-physical, pain, global health status, vitality，social function,role-emotional， mental health.Use score changes to assess improvement in all areas of the patient. Maximum score is147.The higher the score, the better the status in all aspects.
Time Frame
SF-36 Scale was evaluated at 4th week
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:
Patients meeting the diagnostic criteria of Western medicine for IBS-D;
aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
voluntarily signed the informed consent;
local resident who could ensure follow-ups, with basic reading ability
Exclusion Criteria:
Patients with IBS-C, -M, and uncertain forms;
accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism,diabetes, chronic renal insufficiency, and nervous system diseases);
undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
with history of abdominal surgery (e.g., cholecystectomy);
with an allergy history of tested drugs or severe allergy history of food;
pregnant and lactating female;
with a history of neurological or psychiatric disorders;
or participating in other clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fengyun Wang, Ph.D
Phone
+8601062835641
Email
wfy811@163.com
Facility Information:
Facility Name
Xiyuan hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengyun Wang, Ph.D
Email
wfy811@163.com
First Name & Middle Initial & Last Name & Degree
Xia Li, B.S.Med
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang
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