Porwal et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 133 *Corresponding Author: Dr. Ashwin Porwal Founder, Consultant Colorectal Surgeon, Healing Hands Clinic. CLINICAL EVALUATION FOR SAFETY, EFFICACY AND ADVERSE DRUG REACTION OF CONSTAC PLUS AN IMPROVED POLYHERBAL FORMULATION WHEN USED FOR CHRONIC CONSTIPATION 1 *Dr. Ashwin Porwal, 2 Dr. Deepak Kulkarni and 3 Dr. Paresh Gandhi 1 Consultant Colorectal Surgeon, Healing Hands Clinic. 2 General Surgeon, Healing Hands Clinic. 3 General Surgeon, Healing Hands Clinic. 4th floor, Millennium Star Extension, Above KFC, Adjacent to Ruby Hall Clinic, Dhole Patil Road, Pune, Maharashtra, India. Article Received on 30/05/2018 Article Revised on 20/06/2018 Article Accepted on 10/07/2018 INTRODUCTION Chronic constipation is a common symptom, to date no international consensus has been reached regarding its definition. Inability to completely evacuate the bowels or passing very hard stools is known as Constipation or Vibandh in Ayurveda. Defecation is a natural process where discharge of faeces goes out from the body. [1] While defecation lack of satisfaction, reduced/infrequent frequency of stools or difficulty/prolonged evacuation, too small, too hard while stool passage, [2] increases the probability of having constipation in the individuals. Bloating, abdominal pain, pelvic pain, nausea are the non-specific symptoms sometimes associated with the constipation. [3] Such individual come to clinic with the symptoms which include straining, difficulty in passing out stool, after stool passing feeling of dissatisfaction, taking too much time to pass out stool, requirement of maneuvers to take out stool from body, and presence of all these for from 3 to 12 months, [4] could be chronic constipation. It has been reported to be more common in women, non-whites and elderly people aged >65 years. The prevalence of constipation ranges from 8.75% in Asia Pacific, [5] and based on the Rome III criteria its varying levels around the world, from 8.2% to 32.9%. [6,7] In India also constipation is a common scenario but individually it varies in clinical presentation and traditional medicines were used to get relief from the symptoms since the ancient times effectively. In Ayruveda many single medicines, polyherbal formulations, and now a day many proprietary formulations are also suggested to get relief from the symptoms. In Healing hands clinic a 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. OBJECTIVE 1. To Evaluate the safety, and efficacy of improved constac plus formulation in patients with constipation. 2. To evaluate the treatment caused adverse drug reaction after using constac plus. wjpmr, 2018,4(8), 133-136 SJIF Impact Factor: 4.639 Research Article ISSN 2455-3301 WJPMR WORLD JOURNAL OF PHARMACEUTICAL AND MEDICAL RESEARCH www.wjpmr.com 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.