Efficacy and Safety of a Fixed Dose Combination of Paracetamol, Chlorpheniramine Maleate, Phenylephrine and Caffeine in Treatment of Common Cold: A Phase IV, Open-Labelled, Multi-Centric Study

Common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. It also leads to reduction in subjective alertness and impaired psychomotor functioning. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyeretic, Chlorpheniramine maleate, an anti-histaminic, and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Addition of caffeine enhances alertness and psychomotor functioning. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold. Methods: This was a phase IV, open-labelled, multicentric study in 262 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study. Results: There was reduction in mean TSS from 7.67 (day 1) to 3.78 (day 3) and 0.66 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 59.16 % patients had complete relief from the symptoms at the end of study. Out of 262 patients, 46 i.e. 17.56% experienced adverse event. Sedation and drowsiness (12.21%) was the most common adverse event seen in patients. Conclusion: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, Phenylephrine and Caffeine is safe and effective in the treatment of common cold.

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

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.