CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 133 enrolled
Drug / intervention
Normal (0.9%) saline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01547130
NCT01547130Phase 2Completed

A Single Blind, Parallel Group, Randomized Controlled Trial Comparing Solution PEG Based Colon Preparation (HalfLytely) Versus Bolus Luke Warm Saline (Shudh) and Yoga Exercise for Large Bowel Cleansing Prior to Colonoscopy

Arya, Vijaypal, M.D., P.C.·interventional·Posted Mar 7, 2012·Updated Mar 4, 2015

In Brief

A Phase 2 clinical trial evaluating Normal (0.9%) saline and HalfLytely for Colonic Neoplasms. Completed, enrolled 133 participants across 1 site.

Detailed Summary

A quality colonoscopy examination remains as the gold standard for colorectal cancer screening, but effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. Currently, the most widely used cleansing methods employ balanced electrolyte-polyethylene glycol (PEG) solutions. However, a very large volume of PEG solution is required for it to be effective, and many patients refuse to drink a sufficient amount due to non-palatability. In this study, the investigators compare a novel colon preparation method--bolus lukewarm saline with yoga exercise--with a PEG based solution (HalfLytely) for large bowel cleansing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2012
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.3 years ago

Interventions

Normal (0.9%) salinedrug

A total of 2L solution at lukewarm temperature (37.2-38.8 degrees Centigrade)consumed as bolus intake (8-16 oz in one to two minutes) alternating with yoga exercises.

HalfLytelydrug

A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.