There were 214 pediatric patients screened and 66 were included; 32 in Group 2 and 34 in Group 3. Based on age, the subjects were mostly 6-10 years (39/66 or 59%) with 18.2% each in 0-5 and 11-15 years and 4.6% were between 16-20 years old. The mean age was 8.3 years for both groups among those completed treatment.
The drop-out rate was 22% (7/32) for Group 2 and 24% (8/34) for Group 3 with 26 patients completing therapy.
As to response to therapy, there were 20/26 or 75.9% who responded in Group 2 and 81% (21/26) in Group 3. Initial statistical analysis showed no significant differences in the two groups (Placebo and high dose Lagundi Syrup) based on drop-out rate, non-response and good response to therapy after 8 days treatment. (Author)
Note:
Phase II: Clinical stusies done in lagundi tablet as anticough.