Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang
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|ClinicalTrials.gov Identifier: NCT04122586|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|IBS (Irritable Bowel Syndrome)||Drug: Tongxieyaofang(granule)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients " of Tongxieyaofang|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
|No Intervention: health control group|
|Experimental: Tongxieyaofang granule group||
Take this granule twice a day,one bag for each time,one hour after a meal,for 4 weeks
- Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale [ Time Frame: IBS-SSS was evaluated by patients at 4th week ]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） [ Time Frame: BSFS was evaluated by patients at 4th week ]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.
- IBS-D PRO Scale [ Time Frame: IBS-D PRO Scale was evaluated at 4th week ]Grading from the field of physiology, independence, and psychology，Use score changes to assess improvement in all areas of the patient.
- SF-36 Scale [ Time Frame: SF-36 Scale was evaluated at 4th week ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122586
|Contact: fengyun Wang, Ph.Dfirstname.lastname@example.org|
|Beijing, Beijing, China, 100091|
|Contact: Fengyun Wang, Ph.D email@example.com|
|Principal Investigator: Xia Li, B.S.Med|