Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang

NCT04122586 | Unknown DMC

• 1 other identifier: 81774304
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS (Irritable Bowel Syndrome)

Keywords

IBS-D

Outcome Measures

Primary Outcomes (2)

• 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.

  IBS-SSS was evaluated by patients at 4th week

• 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.

  BSFS was evaluated by patients at 4th week

Secondary Outcomes (2)

• IBS-D PRO( patient reported outcomes) Scale

  IBS-D PRO Scale was evaluated at 4th week

• SF-36(the MOS item short from health survey)Scale

  SF-36 Scale was evaluated at 4th week

Study Arms (2)

health control group

NO INTERVENTION

Tongxieyaofang granule group

EXPERIMENTAL

Drug: Tongxieyaofang(granule)

Interventions

Tongxieyaofang(granule) DRUG

Take this granule twice a day,one bag for each time,one hour after a meal,for 4 weeks

Tongxieyaofang granule group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Xiyuan hospital

Beijing, Beijing Municipality, 100091, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

fengyun Wang, Ph.D

CONTACT

+8601062835641; wfy811@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 10, 2019
• Study Start: August 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: January 2, 2020

Record last verified: 2019-10

Locations

CN (1)