Thanawala Shefali, Shah Rajat, Somepalli Venkateswarlu, Alluri KrishnaRaju Venkata, Desomayanandam Prabakaran, Bhuvanendran Arun
Inventia Healthcare Ltd., Mumbai, Maharashtra, India.
Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India.
Clin Pharmacol. 2021 May 21;13:91-100. doi: 10.2147/CPAA.S307464. eCollection 2021.
Knee pain causes functional limitations, eventually compromising the quality of life. We evaluated the efficacy of our water-dispersible turmeric formulation (60% natural curcuminoids, TurmXTRA 60N-WDTE60N), which exhibited better PK profile at low dose (250 mg) than standard turmeric extract, in alleviating symptoms of chronic knee pain.
In this randomized, double-blind, placebo-controlled trial, subjects received either 250 mg WDTE60N capsule (150 mg curcuminoids; n = 53) or appearance-matched placebo capsule (n = 53) once daily for 90 days. Primary endpoint was change in pain score on the visual analogue scale (VAS) after 80-m fast-paced walk test.
A total of 96 subjects completed the study. WDTE60N reduced VAS score from baseline (5.4 ± 0.9) to day 90 (3.8 ± 0.8) with greater mean reduction than placebo (-1.5 ± 0.7 vs -0.6 ± 0.8, < 0.0001; 2.5 times). It also significantly improved the time taken for 80-m fast-paced walk test and 9-step stair-climb test; and improved all biomarkers compared to placebo ( > 0.05). Three adverse events occurred but were unrelated to study products.
WDTE60N 250 mg administered once daily for 3 months, alleviated knee pain, improved joint function in healthy subjects with chronic knee pain, was well tolerated and safe.
膝关节疼痛会导致功能受限,最终影响生活质量。我们评估了我们的水分散性姜黄制剂(60%天然姜黄素类化合物,TurmXTRA 60N-WDTE60N)在缓解慢性膝关节疼痛症状方面的疗效,该制剂在低剂量(250毫克)时的药代动力学特征优于标准姜黄提取物。
在这项随机、双盲、安慰剂对照试验中,受试者每天服用一次250毫克WDTE60N胶囊(150毫克姜黄素类化合物;n = 53)或外观匹配的安慰剂胶囊(n = 53),持续90天。主要终点是80米快步行走试验后视觉模拟量表(VAS)上疼痛评分的变化。
共有96名受试者完成了研究。WDTE60N使VAS评分从基线时的(5.4±0.9)降至第90天时的(3.8±0.8),平均降低幅度大于安慰剂(-1.5±0.7对-0.6±0.8,<0.0001;2.5倍)。它还显著改善了80米快步行走试验和9级楼梯攀爬试验所需的时间;与安慰剂相比,所有生物标志物均有所改善(>0.05)。发生了3起不良事件,但与研究产品无关。
每天服用一次250毫克WDTE60N,持续3个月,可缓解慢性膝关节疼痛健康受试者的膝关节疼痛,改善关节功能,耐受性良好且安全。