POST-MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ZINC GLUCONATE IN PAEDIATRIC PATIENTS OF DIARRHOEA
Dr. Mayuresh Kiran*, Lalit Pawaskar, Pramita Waghambare and Shaheen Sheikh
ABSTRACT
Introduction: Diarrhoea is characterised by loose, watery tools, nausea, stomach cramps, pains and other symptoms. Zinc supplementation is considered to be efficacious to minimise the frequency and severity of diarrhoea. Zinc has been recommended for the treatment of diarrhoea by the WHO and the UNICEF since 2004. If Zinc is paired with oral rehydration solution (ORS) and continued feeding, diarrhoeal morbidity and mortality can be minimised. This study was conducted to determine the efficacy and safety for Zinc Gluconate equivalent to elemental Zinc 20 mg per 5ml for the treatment of diarrhoea in paediatrics in Indian population. Method: A total 180 trial subjects were enrolled for the study. The study was conducted for the duration of 14 days in which the efficacy was analysed till day 5 as normally the diarrhoea gets managed within 5 days and the safety was analysed till day 14. The improvement in stool consistency and the decrease in average stool frequency were used to determine efficacy. To evaluate safety, the occurrence and severity of the reported adverse events were measured. Results: 166 trial subjects completed the study. The average stool frequency was 8.73 on day 1 reduced to 4.19 on day 3 and further reduced to 1.89 on day 5. During the study improvement in stool consistency was also observed. Adverse events reported by trial subjects were of non-serious and expected nature. Conclusion: Zinc Gluconate was found to be efficacious and safe for the treatment of diarrhoea when given along with the ORS.
Keywords: Zinc Gluconate, Efficacy, safety, diarrhoea.
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