Safety and Efficacy of a Combination of Cyproheptadine and Tricholine Citrate: Phase IV Study

ABSTRACT

Background:Undernutrition or anorexia is very common in infants and children in developing countries like India. An FDC of Cyproheptadine and Tricholine Citrate, an appetite and growth stimulant is popular in the treatment of undernutrition or anorexia. The phase IV clinical study was conducted for evaluating the efficacy and safety of combination of Cyproheptadine and Tricholine Citrate in the treatment of undernutrition or anorexia in infants and children. Methods: Out of 322 patients, 279 patients completed the study. Safety assessment was made by inspecting the adverse events during trial. Efficacy assessment was made by analysis the increase in appetite and meal frequency. Safety assessment was made by analysing the adverse events during the clinical trial. Result: Average increase in meal frequency and change in meal quantity (very low/low/moderate/high/very high) was analysed at all three visit. As compared to baseline visit, it was found that in conclusion visit the patients with very low and low appetite shifted to moderate and high appetite and some patients were found with very high appetite. The average meal frequency as compared to baseline visit was found out to be increased in conclusion visit. Conclusion: The combination of Cyproheptadine and Tricholine Citrate is safe and effective for the treatment of undernutrition or anorexia in infants and children.