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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Take this granule twice a day,one bag for each time,one hour after a meal,for 4 weeks
Xiyuan hospital
Beijing, Beijing Municipality, China
RECRUITINGIrritable 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
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
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
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
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