The safety and effect of Plaortawan extract on enhancing immunity in normal healthy volunteers (clinical trial phase I)

Abstract

Introduction: Plaortawan is a herb with immunity enhancing activity in animal but has not been studied in human.As no modern drug could cure the HIV. So the researchers are interested in studying a clinical trialphase I to identify safety and effect of Plaortawan extract on enhancing immunity in normal volunteers.

Method: Twenty normal volunteers were divided into 10 males and 10 females aged 20-45 years. After screening,each subject took Plaortawan extract 300 mg./day for 28 days. The subjects would be followed upfor signs, symptom and laboratory test on D₇, D₁₄ ,D₂₁, D₂₈ after taking medication and after stopmedication for 7 days on D₃₅

Results: During taking Plaortawan extract, 7 volunteers had liver enzymes, aspartate aminotransferase (AST) andalanine aminotransferase (ALT), increased signifi cantly but none in 13 subjects. There were no obviouschanges in CD4, CD8 and CD4:CD8 ratio.

Conclusion: To take Plaortawan extract 300 mg./day for 28 days could be the cause of increasing liver enzymes buthad no effect on CD4, CD8 and CD4:CD8 ratio of the volunteers.

Key words: Plaortawan, Immune, Clinical trial phase I