Monotherapy with Kutaj Parpati Is Effective in reducing Irritable Bowel Syndrome (IBS) Symptoms - A Randomized controlled, parallel group trial

2021 ◽  
pp. 1
Author(s):  
Manjiri Ranade
Keyword(s):  
Irritable Bowel Syndrome ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Irritable Bowel ◽  
Parallel Group Trial ◽  
Group Trial

scholarly journals The Tiotropium Safety and Performance in Respimat® Trial (TIOSPIR®), a large scale, randomized, controlled, parallel-group trial-design and rationale

2013 ◽  
Vol 14 (1) ◽  
pp. 40 ◽  
Author(s):  
Robert A Wise ◽  
Antonio Anzueto ◽  
Peter Calverley ◽  
Ronald Dahl ◽  
Daniel Dusser ◽  
...  
Keyword(s):  
Trial Design ◽  
Large Scale ◽  
Randomized Controlled ◽  
Parallel Group ◽  
And Performance ◽  
Parallel Group Trial ◽  
Group Trial

scholarly journals Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR)

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Igor Monsellato ◽  
Filippo Alongi ◽  
Elisa Bertocchi ◽  
Stefania Gori ◽  
Giacomo Ruffo ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Pathologic Complete Response ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Timing Of Surgery ◽  
Rectal Cancer Surgery ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Parallel Group Trial ◽  
Group Trial

Abstract Background The optimal timing of surgery in relation to chemoradiation is still controversial. Retrospective analysis has demonstrated in the recent decades that the regression of adenocarcinoma can be slow and not complete until after several months. More recently, increasing pathologic Complete Response rates have been demonstrated to be correlated with longer time interval. The purpose of the trial is to demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathologic Complete Response and reflects on disease-free survival and overall survival rather than standard timing. Methods The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and forty patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. Discussion To date, it is well-know that pathologic Complete Response is associated with excellent prognosis and an overall survival of 90%. In the Lyon trial the rate of pCR or near pathologic Complete Response increased from 10.3 to 26% and in retrospective studies the increase rate was about 23–30%. These results may be explained on the relationship between radiation therapy and tumor regression: DNA damage occurs during irradiation, but cellular lysis occurs within the next weeks. Study results, whether confirmed that performing surgery after 12 weeks from neoadjuvant treatment is advantageous from a technical and oncological point of view, may change the current pathway of the treatment in those patient suffering from rectal cancer. Trial registration ClinicalTrials.gov NCT3465982.

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