Efficacy of Lactulose versus combination of Senna and Ispaghula husk in Pre-Dialysis Chronic kidney disease patient with Constipations: A Randomized Controlled Trial

Phase 3

Completed

• Conditions: Chronic kidney disease, Lactulose, Ispaghula husk, Senna, Constipation; pre- dialysis CKD patients with constipation who follow up at Phramongkutklao Hospital, Bangkok, Thailand

• Registration Number: TCTR20200818006
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-12-06
• Study Start: 2020-08-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

CKD stage 4 and 5 with non-dialysis, aged > 18 years, who were diagnosed constipation by ROME IV criteria

Exclusion Criteria

history of abdominal surgery, gut obstruction, pregnancy, end stage renal disease who on dialysis, history of lactulose, senna, fiber allergy, and history of bulimia and anorexia. Discontinuation criteria included unwillingness to continue study, intolerable side-effects or allergy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
compare efficacy of lactulose and combination of senna and ispaghula husk for treat constipations in 14 days complete spontaneous bowel movement (CSBM) per week which complete spontaneous was assessed using st

Secondary Outcome Measures

Name	Time	Method
change of stool appearance 14 days Bristol stool form scale (BSFS).