Table 3_A standardized combination of Boswellia serrata and Terminalia chebula extracts to improve cognition in adults with subjective memory complaints: a randomized controlled proof-of-concept study.docx

ObjectiveBoswellia serrata (Indian frankincense) and Terminalia chebula (haritaki) are botanicals widely used in Indian Ayurvedic Medicine for cognitive health. This randomized, double-blind, placebo-controlled proof-of-concept study evaluated the effectiveness of LN19184, a unique, standardized blend of B. serrata gum resin and T. chebula fruit extracts, to improve cognitive function, sleep quality, and brain-derived neurotrophic factor (BDNF) levels in aging individuals.
MethodsOne hundred participants aged 40–65 with subjective complaints of poor memory were randomized into two groups: 300 mg of LN19184 or placebo, once daily for 120 days. At baseline and days 15, 30, 60, and 120, two neuropsychological batteries, the Rey’s Auditory Verbal Learning Test (RAVLT) and the Cambridge Neuropsychological Test (CANTAB), were used to assess cognitive function, and the Athens Insomnia Scale was used to evaluate sleep quality. Serum BDNF levels and safety parameters were also assessed.
ResultsLN19184 improved each measured RAVLT outcome compared to placebo. Supplementation improved proactive interference (p < 0.001) and recognition index (p = 0.004) by day 15. Learning rate, total learning, and delayed recall improved by day 60 (p < 0.001), and immediate recall improved by day 90 (p = 0.003). Compared to placebo, supplementation also improved CANTAB assessments of visual learning, processing speed, and accuracy (p < 0.05), sleep quality (p < 0.001), and serum BDNF levels (p < 0.001). Vital signs and safety parameters remained within normal clinical limits throughout the study.
ConclusionThis pilot trial provides early empirical evidence demonstrating that a novel extract blend of B. serrata and T. chebula was well tolerated and improved cognitive function, sleep quality, and peripheral BDNF levels in aging adults with memory complaints.
Clinical trial registrationClinicaltrials.gov, identifier CTRI/2020/08/027368.

研究目的：乳香树（Boswellia serrata，印度乳香）与诃子（Terminalia chebula，哈立卡）是印度阿育吠陀医学中广泛用于认知健康的植物药。本项随机双盲安慰剂对照概念验证研究，旨在评估LN19184——一种由乳香树树胶树脂与诃子果实提取物制成的独特标准化混合物——对中老年人群认知功能、睡眠质量及血清脑源性神经营养因子（BDNF）水平的改善效果。研究方法：招募100名年龄在40~65岁之间、主观主诉记忆力减退的受试者，随机分为两组，每日单次口服300 mg LN19184或安慰剂，干预周期为120天。分别在基线及第15、30、60、120天，采用两套神经心理学测试组合——雷伊听觉词语学习测验（RAVLT）与剑桥神经心理自动化成套测验（CANTAB）——评估受试者的认知功能，并采用雅典失眠量表评估其睡眠质量；同时检测受试者血清BDNF水平及各项安全性指标。研究结果：与安慰剂组相比，LN19184可改善RAVLT的各项检测指标。干预至第15天时，补充LN19184可改善前摄干扰（p<0.001）与再认指数（p=0.004）；至第60天，学习速率、总学习量及延迟回忆均得到改善（p<0.001）；至第90天，即刻回忆能力得到提升（p=0.003）。与安慰剂组相比，LN19184补充还可改善CANTAB评估的视觉学习能力、信息处理速度与准确率（p<0.05），同时提升睡眠质量（p<0.001）及血清BDNF水平（p<0.001）。整个研究期间，受试者的生命体征及各项安全性指标均维持在临床正常范围内。研究结论：本项先导临床试验提供了初步的实验证据，表明这种新型乳香树与诃子提取物混合物耐受性良好，可改善主诉记忆力减退的中老年人群的认知功能、睡眠质量及外周血BDNF水平。临床试验注册：Clinicaltrials.gov，登记号CTRI/2020/08/027368。