A comparative clinical study to evaluate the effectiveness of Amalaki fortified biscuits as a nutritional suppliment in adolescents with iron deficiency anaemia

It is a comparative clinical trial. Total number of sample is 100  . With alternate allocation samples are grouped into two groups. Group A with 50 samples will be screened for iron deficiency anaemia and  given Amalaki fortified biscuits for 90 days. two biscuits weighing 20grams each will be given afternoon in the empty stomach after confirming the dewormin treatment within 6 months. Group B with 50 samples will be screened for iron deficiency anaemia and given control drug punarnava mandura for 90 days  Two tablets of 500mg each will be given in the afternoon empty stomach. The volunteers will be assessed for subjective and objective parameters. The symptoms will be assessed before intervention, on 30th day, 60th day and after completion of intervention. The biochemical parameters will be assessed before and after completion of intervention.Assessment will be done based on grading and improvements/changes in subjective as well as objective parameters before during and after treatment. Panduta, Hatanala Dourbalya, Shrama, Aarohanaayasa, Bhrama, Hrudrava, Karnakshweda, Aruchi, Agnimandyam, Shirnalomata, Pindikodweshtanam, Tama darshana, Hridayaspandanadhikya  will be evaluated for their presence. Hb%, serum iron, Serum ferritin and TIBC (if possible in randomly few cases) will be assessed pre and post intervention. Frequency tables and crosstabs would be generated for all the variables considered. Association with demographic and exposure variables would be worked out using the chi-square test. If the variable is a scale variable paired t-test, ANOVA, student’s t-test, and repeated measures ANOVA would be used to test the effect of the intervention. If in case the variable is ordinal nominal, the Wilcoxon sign rank test, Friedman and Mann-Whitney U test would be used.  Advanced statistics tests would be conducted based on the data availability.