CLINICAL EVALUATION FOR SAFETY, EFFICACY AND ADVERSE DRUG REACTION OF CONSTAC PLUS AN IMPROVED POLYHERBAL FORMULATION WHEN USED FOR CHRONIC CONSTIPATION
*Dr. Ashwin Porwal, Dr. Deepak Kulkarni and Dr. Paresh Gandhi
ABSTRACT
Defecation is a natural process where waste discharge as faeces goes out from the body. While defecation lack of satisfaction, reduced/infrequent frequency of stools or difficulty/prolonged evacuation, too small, too hard while stool passage increases the probability of having constipation in the individuals. The prevalence of constipation ranges from 8.75% in Asia Pacific. With respect to Indian Population Constipation Scoring System were used in 170 participants Total 7(3.3%) participants reported the adverse events which includes nausea (22%), vomiting (17%), diarrhea (22%), abdominal pain (26%), Heart Burn (acidity) (13%) while taking follow up and decided not to continue further in the study. Mean (SD) of total 170 participants in constipation scoring system before treatment was 17.41 with range of 16, 29. All participant were analyzed for the score from 2nd week Mean (SD) was 14.70(6.50), 4th Week Mean (SD) 13.45(6.48), 8th Week Mean (SD) 11.04(5.81), 16th Week (SD) 8.04(5.17), 24th week Mean (SD) 5.13(3.29). Results show continuous decrease in mean value of total score and improvement in constipation symptoms reported by participants. In this new improved formula is been formulated and clinical evaluations were done in this study to see efficacy; safety treatment caused adverse events (TCAD) of Constac Plus powder in chronic constipation.
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