Dufour Jaustin, Lin Xinjie Lois, Wang Jun, Baisley Joshua, Atif Ambreen, Berthold Erin C, Atallah Ramsey
Medical Writing, Nutrasource Pharmaceutical and Nutraceutical Services Inc., Guelph, CAN.
Biostatistics, Nutrasource Pharmaceutical and Nutraceutical Services Inc., Guelph, CAN.
Cureus. 2024 Dec 13;16(12):e75654. doi: 10.7759/cureus.75654. eCollection 2024 Dec.
This study investigates the safety of three different daily dosages of a liquid blend containing kava and kratom (Feel Free® Classic Tonic {FFCT}) in healthy adults over six consecutive days of supplementation. Both kava and kratom have been used traditionally for hundreds of years, but there is limited data on the combined safety of these ingredients. In this randomized, double-blind, placebo-controlled trial, the participants were assigned to receive one of three daily dosages of FFCT or placebo. Safety assessments included the monitoring of vital signs, clinical chemistry, hematology, and withdrawal symptoms using the Clinical Opiate Withdrawal Scale (COWS) and the Subjective Opiate Withdrawal Scale (SOWS). The results indicate that FFCT was safe, with mild to moderate adverse events (AEs) such as nausea, headaches, and fatigue, particularly in the high-dosage (HD) group. No significant changes in liver or kidney function were noted, and all vital signs remained within normal physiological ranges although some statistically significant changes in blood pressure (BP) and respiratory rate (RR) were observed. There were no clinically significant observations in COWS or SOWS scores despite a small but statistically significant increase in COWS total score in the high-dose group on day 7. Overall, FFCT appears safe for short-term use in healthy adults, with no significant impact on vital signs, laboratory values, or withdrawal symptoms.
本研究调查了一种含有卡瓦和 kratom 的混合液（Feel Free® Classic Tonic {FFCT}）的三种不同日剂量在健康成年人连续六天补充期间的安全性。卡瓦和 kratom 传统上已被使用数百年，但关于这些成分联合使用安全性的数据有限。在这项随机、双盲、安慰剂对照试验中，参与者被分配接受三种日剂量的 FFCT 或安慰剂中的一种。安全性评估包括使用临床阿片戒断量表（COWS）和主观阿片戒断量表（SOWS）监测生命体征、临床化学、血液学和戒断症状。结果表明，FFCT 是安全的，有轻度至中度不良事件（AE），如恶心、头痛和疲劳，特别是在高剂量（HD）组。未观察到肝脏或肾脏功能有显著变化，尽管观察到血压（BP）和呼吸频率（RR）有一些统计学上的显著变化，但所有生命体征仍保持在正常生理范围内。尽管高剂量组在第 7 天 COWS 总分有小幅但统计学上显著的增加，但在 COWS 或 SOWS 评分方面没有临床显著观察结果。总体而言，FFCT 似乎对健康成年人短期使用是安全的，对生命体征、实验室值或戒断症状没有显著影响。
