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一项多中心、随机、双盲、安慰剂对照试验,评估一种新型低剂量姜黄提取物制剂在患有慢性膝关节疼痛的健康成年人中的疗效和安全性。

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Efficacy and Safety of a Novel Low-Dose Turmeric Extract Formulation in Healthy Adults with Chronic Knee Pain.

作者信息

Thanawala Shefali, Shah Rajat, Somepalli Venkateswarlu, Alluri KrishnaRaju Venkata, Desomayanandam Prabakaran, Bhuvanendran Arun

机构信息

Inventia Healthcare Ltd., Mumbai, Maharashtra, India.

Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India.

出版信息

Clin Pharmacol. 2021 May 21;13:91-100. doi: 10.2147/CPAA.S307464. eCollection 2021.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

背景

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。

方法

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。

结果

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。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a6/8149286/507e8174e6a7/CPAA-13-91-g0001.jpg

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