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Status unknownNCT04122586Updated Jan 2, 2020

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

An interventional study of Tongxieyaofang(granule) in IBS (Irritable Bowel Syndrome), sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Aug 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • IBS (Irritable Bowel Syndrome)

Keywords

  • IBS-D
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In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    health control group
  • Experimental
    Tongxieyaofang granule group

    Drug: Tongxieyaofang(granule)

Interventions

  • DrugTongxieyaofang(granule)

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: IBS-SSS was evaluated by patients at 4th week

  2. 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.

    Time frame: BSFS was evaluated by patients at 4th week

Secondary outcomes

  1. 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.

    Time frame: IBS-D PRO Scale was evaluated at 4th week

  2. 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.

    Time frame: SF-36 Scale was evaluated at 4th week

07

Study locations

1 of 1 sites recruiting
  • Xiyuan hospital
    Beijing, Beijing 100091, China
    • Fengyun Wang, Ph.D · Contact · wfy811@163.com
    • Xia Li, B.S.Med · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04122586
Lead sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Responsible party
Sponsor
First posted
Oct 10, 2019
Start date
Aug 1, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jan 2, 2020

Study contacts

fengyun Wang, Ph.D
Contact
wfy811@163.com
+8601062835641

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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