A Single Centric, Open Label, Non-Randomized Phase IV Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Product PETSAFFA in Subjects Suffering from Constipation

The Study has been designed to measure the efficacy and safety of product PETSAFFA in subjects suffering from constipation. The Study is single centric, open label, Non-randomized, Phase IV Post marketing surveillance study on 120 subjects. There are four visits in the study with one telephonic follow-up. On screening visit i.e., day 0, the subjects will be screened based on inclusion and exclusion criteria. An informed consent form will be given to all subjects at the screening visit containing all study information in it. After obtaining the consent form, blood will be drawn for laboratory investigations (CBC, Serum creatinine and SGPT). Eligible subjects will be enrolled in the study after the baseline visit (i.e., visit 2). The study Investigator will explain the subject about all study-related processes and the telephonic follow-up Day 14 (Visit 3) and final visit Day 21 (Visit 4). All eligible subjects will then be provided with Test Product – PETSAFFA by Investigator/study co-ordinator on day 1. In the presence of Investigator, the instructions will be given to use the test product at home from Day 1 to Day 21 i.e., Oral administration of 1 teaspoon of PETSAFFA granules with lukewarm water at night before bed. Investigator assessment shall be performed on baseline Day 0 and final visit- Day 21. A self- assessment questionnaire shall be given to all eligible subjects on Baseline and final visit. Blood investigations shall be performed on baseline and final visit.