Effectiveness and Safety of Kleeb Bua Daeng: A Thai Folk Remedy for Insomnia

Abstract

Insomnia is a commonly found condition which affects the quality of life of the general population world  wide. Chao Phraya Abhaibhubejhr Hospital (CAH) has incorporated a folk insomnia remedy, Kleeb Bua Daeng (KBD), which contains Nelumbo nucifera Gaertn., Centella asiatica(L.)UrbanandPiper nigrum L. into the hospital formulary since 2017. This study aimed to evaluate the effectiveness and safety of KBD insubjects with insomnia as identified by Pittsburgh Sleep Quality Index (PSQI) score of more than 5 who attended CAH’s Department of Thai Traditional and Alternative Medicine from May 1, 2017 to January 5, 2020.Fifty subjects with a mean age of 48.48 ± 14.31 years had an average PSQI score of 12.22 ± 3.12 at baseline. All participants received 2capsules of KBD (400 mg/capsule) after breakfast and before bedtime (4 capsules/day) for 4 weeks. KBD improved sleep quality with PSQI scores of 8.66 ± 3.23, 7.12 ± 3.04, 6.06 ± 2.75, and 5.30 ± 2.61 after 1, 2, 3, and 4 weeks of medications, respectively – the qualities improving significantly after the first week (p < 0.01). Regarding drug safety, there were 9 and 5 cases reporting adverse product reactions (APR) during the first three weeks and the fourth week, respectively. The adverseproduct reactions were frequent urination, giddiness/vertigo, hypotension, constipation and gastro intestinal disturbance. It has been concluded that KBD is effective and safe for improving sleep quality. However, continuous monitoring of this remedy’s efficacy should be further undertaken to see if the remedy could reduce the PSQI score to less than 5 which indicates no clinically significant insomnia.