Clinical safety
Phase I clinical studies on has indicated that it is safe and well tolerated in healthy adults and elderly volunteers. No side effects were reported in any of the treated volunteers. The physical, hematological and biochemical parameters were within the normal limits.
No clinically significant side effects were observed in phase II clinical studies on in elderly and children requiring Individual Education Programme (IEP).


Preclinical safety
Oral administration of (500mg/kg body weight) for 90 days did not cause any mortality and significant adverse effects in rats.
LD₅₀ of was found to be 2400mg/kg p.o. in rats.
did not induce mutations in S. typhimurium at and up to the maximum concentration of 5000µg/plate.
did not induce significant number of chromosome aberrations at any of the concentrations (0.312, 0.625, and 1.25 mg/culture tested) in human lymphocyte cells.


Dosage
For adult - 300-450 mg/day for 12 weeks.
For children - 225mg/day for 16 weeks.