Safety and Pharmacokinetics Study of Boesenbergia rotunda (L.) Mansf. Capsules in Healthy Thai Volunteers: A Phase 1 Clinical Study
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Abstract
Introduction and objective: Recently, there are a number of preclinical studies of “KraChai” or “Finger root”, Boesenbergia rotunda (L.) Mansf., showing its efficacy as anti-inflammation and anti-viral including SARS CoV-2. However, no report of its efficacy in clinical trials. This study therefore aims to study pharmacokinetics of Boesengergia rotunda (L.) Mansf. extract with 2 active pharmaceutical substances which are Pinostrobin and Panduratin A, as well as to study the safety of KraChai extract containing Pinostrobin and Panduratin A not less than 30 mg and 9 mg, respectively.
Method: This study was conducted in 11 healthy volunteers. All healthy volunteer was assigned to take 3 capsules of KraChai extract per meal and 3 meals a day continuously for 7 days.
Result: After taking KraChai extract for 7 consecutive days, the result showed that the maximum concentration of Pinostrobin and Panduratin A were 15.07±6.66 and 63.26±21.73 ng/mL., respectively. The maximum concentration time (Tmax) were 2.67±0.89 h and 3.00±0.95 h., respectively. The half-life value (T1/2) of Pinostrobin and Panduratin A were 8.07±2.93 h and 5.51±2.62 h., respectively. No adverse events have been reported. Additionally, characteritics of blood pressure and body temperature were normal. However, this study found the Hematological Blood Profile revealed significant trends in Hemoglobin (Hb), Hematocrit (Hct), Red blood cell (RBC), and Blood Urea Nitrogen (BUN), with significant decreasing level by p value <0.01, 0.02, <0.01, and 0.02, respectively. Also this study found significant increasing level of Total CO2 with p-value at 0.01. However, when stop taking KraChai extract after 3 days (Day10) the level of BUN and Total CO2 had returned into normal stage, while the level of Hemoglobin, Hematocrit and RBC were remained low within a normal range with p-value <0.01, <0.01 and <0.01, respectively. Moreover, this study found significant decreasing level of C-reactive protein (p-value = 0.04).
Discussion: When taking KraChai extract at a dosage of 1,350 mg/day for 7 days consecutively (multiple doses), it was observed that the levels of Pinostrobin and Panduratin A in the blood increased sequentially until reaching their peak levels and then gradually decreased over time. Additionally, the continuous intake of KraChai extract at this specified dosage had no effect on the liver, kidneys, and electrolytes.
Conclusion and Recommendation: This study revealed that intake of KraChai extract capsule, containing Pinostrobin and Panduratin A at amount of 270 mg/day and 81 mg/day respectively, 7 days consecutively is safe. This study is also confirming the anti-inflammation property of Boesengergia rotunda (L.) Mansf. extracts in human study.
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