一种新型低剂量水分散性姜黄提取物治疗膝关节骨关节炎的疗效与安全性：一项随机、双盲、安慰剂对照临床试验

Efficacy and Safety of a Novel Low-Dose Water-Dispersible Turmeric Extract in the Management of Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

作者信息

Thanawala Shefali, Shah Rajat, Alluri Krishnaraju Venkata, Bhupathiraju Kiran, Prasad Nandlal, Agarwal Yash

机构信息

Medical Science and Research Department, Nutriventia Limited, Mumbai, Maharashtra, 400069, India.

Executive Management, Nutriventia Limited, Mumbai, Maharashtra, 400069, India.

出版信息

J Pain Res. 2025 Jan 25;18:411-427. doi: 10.2147/JPR.S501505. eCollection 2025.

DOI:10.2147/JPR.S501505

PMID:39882178

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11776925/

Abstract

PURPOSE

Turmeric extract is a well-known nutraceutical ingredient recognized for its benefits in managing musculoskeletal health. This study evaluated the efficacy and safety of a novel low-dose water-dispersible turmeric extract containing 60% natural curcuminoids (WDTE60N) in participants with mild-to-moderate knee osteoarthritis.

PATIENTS AND METHODS

This double-blind, randomized, placebo-controlled trial was conducted at two orthopedic centers in Uttar Pradesh, India (July 2023-November 2023). Participants aged 45-75 years with unilateral or bilateral OA of the knee for >3 months were randomized in 1:1 ratio to receive WDTE60N (250 mg) or placebo capsules once daily for three months. Study endpoints included assessment of changes from baseline to day 90 in pain intensity (visual analog scale [VAS], knee injury and osteoarthritis outcome score [KOOS]), inflammatory biomarkers, and safety profile. Data were analyzed using independent -test, chi-square test, and analysis of co-variance test.

RESULTS

In total, 139 participants (WDTE60N, n = 70; placebo, n = 69) with mean age and BMI of 56.35 years and 23.89 kg/m, respectively, were included. The mean reduction (95% CI) in VAS score from baseline to day 90 was significantly higher in the WDTE60N group than in the placebo group (14.41 [13.08, 15.75] vs 6.02 [5.00, 7.05]; p < 0.0001). In the WDTE60N group, the mean change in VAS scores was significantly reduced from as early as day 07 (p = 0.0076), which continued until day 90 (p < 0.0001), compared to the placebo group. Improvement in the mean KOOS scores (baseline-Day 90) was evident, with significantly higher mean scores for each domain (pain, symptoms, activities of daily living, function in sport and recreation, and knee-related quality of life [QoL]) on Day 90 in the WDTE60N group than in the placebo group (p < 0.05). Inflammatory biomarkers (hsCRP, TNF-α, IL-6, and IL-1β) were significantly reduced from baseline to day 90 in the WDTE60N group compared to the placebo group (p < 0.0001). Four mild adverse events were reported during the study period.

CONCLUSION

Supplementation with the low-dose water-dispersible turmeric extract containing 60% natural curcuminoids for three months was safe and effective in alleviating pain, improving functional status and quality of life and reducing inflammation in participants with mild-to-moderate knee osteoarthritis.

CTRI REGISTRATION NUMBER

CTRI/2023/07/055411.

摘要

目的

姜黄提取物是一种著名的营养保健品成分，因其对肌肉骨骼健康的益处而闻名。本研究评估了一种新型低剂量水分散性姜黄提取物（WDTE60N）的疗效和安全性，该提取物含有60%的天然姜黄素，用于轻度至中度膝骨关节炎患者。

患者与方法

本双盲、随机、安慰剂对照试验在印度北方邦的两个骨科中心进行（2023年7月至2023年11月）。年龄在45 - 75岁、单侧或双侧膝关节骨关节炎超过3个月的参与者按1:1比例随机分组，每天服用一次WDTE60N（250毫克）或安慰剂胶囊，持续三个月。研究终点包括评估从基线到第90天疼痛强度（视觉模拟量表[VAS]、膝关节损伤和骨关节炎结局评分[KOOS]）、炎症生物标志物和安全性的变化。数据采用独立样本t检验、卡方检验和协方差分析进行分析。

结果

总共纳入了139名参与者（WDTE60N组，n = 70；安慰剂组，n = 69），平均年龄和体重指数分别为56.35岁和23.89 kg/m²。从基线到第90天，WDTE60N组的VAS评分平均降低幅度（95%置信区间）显著高于安慰剂组（14.41 [13.08, 15.75] 对 6.02 [5.00, 7.05]；p < 0.0001）。在WDTE60N组中，与安慰剂组相比，VAS评分的平均变化从第7天就显著降低（p = 0.0076），并持续到第90天（p < 0.0001）。WDTE60N组第90天的平均KOOS评分（基线 - 第90天）有明显改善，每个领域（疼痛、症状、日常生活活动、运动和娱乐功能以及膝关节相关生活质量[QoL]）的平均得分均显著高于安慰剂组（p < 0.05）。与安慰剂组相比，WDTE60N组从基线到第90天炎症生物标志物（hsCRP、TNF-α、IL-6和IL-1β）显著降低（p < 0.0001）。研究期间报告了4例轻度不良事件。