Efficacy and Safety of Kleeb Bua Daeng Formula in Mild Cognitive Impairment Patients: A Phase I Randomized, Double-Blind, Placebo-Controlled Trial

Natdanai Musigavong; Chantana Boonyarat; Yaowared Chulikhit; Orawan Monthakantirat; Makorn Limudomporn; Supaporn Pitiporn; Pakakrong Kwankhao; Supawadee Daodee

doi:10.1155/2022/1148112

Efficacy and Safety of Kleeb Bua Daeng Formula in Mild Cognitive Impairment Patients: A Phase I Randomized, Double-Blind, Placebo-Controlled Trial

Evid Based Complement Alternat Med. 2022 Mar 25:2022:1148112. doi: 10.1155/2022/1148112. eCollection 2022.

Authors

Natdanai Musigavong¹, Chantana Boonyarat¹, Yaowared Chulikhit¹, Orawan Monthakantirat¹, Makorn Limudomporn², Supaporn Pitiporn³, Pakakrong Kwankhao³, Supawadee Daodee¹

Affiliations

¹ Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.
² Department of Neurology, Chao Phya Abhaibhubejhr Hospital, Prachinburi 25000, Thailand.
³ Center of Evidence-Based for Thai Traditional and Herbal Medicine, Chao Phya Abhaibhubejhr Hospital, Prachinburi 25000, Thailand.

Abstract

Individuals with mild cognitive impairment (MCI) were at increased risk of conversion to dementia. The Kleeb Bua Daeng (KBD) formula could be the alternative treatment option for MCI through multitarget activities. Lacking of clinical trial information brought about the study 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. Their cognitive functions were monitored by the Montreal Cognitive Assessment (MoCA) and blood chemistry assessment every one month. We found that the KBD-treated group had no significant differences in the MoCA test compared to placebo. Moreover, there was no alteration in biochemical parameters of the liver and renal function was observed which could confirm the safety of this KBD formula.