2.4. Study design
Statistically, a significant sample size was considered for this study. A total of 30 subjects including drop-outs were considered for this clinical study. Further, all the subjects were randomly allocated into 2 treatment groups Active and Placebo. Subjects were randomly assigned to receive either 1 capsule of Consort diagram – flowchart of study procedures, from eligible 30 subjects who fit into inclusion and exclusion criteria, 26 subjects completed the study. At every follow-up visit, study evaluations were made in both study groups.