A Prospective, Open-label, Non-randomised Clinical Trial to Evaluate the Safety and Efficacy of Cholecurb in the Treatment of Dyslipidemia

Abstract

Objectives: To evaluate the clinical efficacy and safety of Cholecurb Tablets in Dyslipidemia. Materials and Methods: A prospective, interventional clinical study was conducted on 55 patients, aged between 18-55 years, confirmed with dyslipidemia and who were willing to give informed consent. All patients received Cholecurb Tablets at a dose of two tablets four times in a day for four weeks. All patients were evaluated at baseline, 45 and 120 days for parameters of fasting plasma lipid profile. The Physician’s global assessment and Patient’s global assessment (at end of the study) on efficacy and tolerability were made on a scale of 1- 5, namely, Very Good = 5, Good = 4, Fair = 3, Poor = 2 and Very Poor = 1. Observation and Results: Cholecurb Tablets significantly improved all lipid outcomes at both 45 days and 120 days after onset of treatment. There were no significant differences in the laboratory findings at baseline, 45 days and 120 days. The global assessment of response by physicians showed that 72% of patients showed a good improvement while another 16% showed very good improvement in their condition by the end of 120 days of treatment. Similarly, 58% and 31% of the patients’ global assessment indicated good and very good response at the end of treatment, respectively. These findings confirm the efficacy of Cholecurb Tablets in the study population during the study period. Conclusion: Cholecurb Tablets typically lowered LDL, TG, TC and elevated HDL, assessed at baseline, 45 days and 120 days. There were no clinically significant adverse events either reported or observed during the entire study period.