Title: Efficacy and safety of Kleeb Bua Daeng formula in mild cognitive impairment patients: A phase I randomized, double-blind, placebo-controlled trial

Abstract

Individuals with mild cognitive impairment (MCI) were at increased risk of conversion to dementia. The KleebBuaDaeng (KBD) formula could be the alternative treatment option for MCI through multi-target activities. However, the lack of clinical trial, therefore, need to be studied in our research. Forty patients with MCI were randomly assigned to receive the KBD capsule or placebo at a dose of 1,000 mg twice a day for three months. They were monitored cognitive functions by the Montreal Cognitive Assessment (MoCA) assessment test and blood chemistry assessment every one month. We found that the KBD-treated group had no significant differences on the MoCA test compared to placebo. Moreover, there was no alter in biochemical parameters of the liver, and renal function was observed which could confirm the safety of this KBD formula.