Jeffrey Pradeep Raj, Shreeraam Venkatachalam, Rajkumar S Amaravati
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Turmacin® was administered for seven days to 15 healthy volunteers as four capsules of 500 mg each in the morning with food. The stair mill at a speed of 60 steps per minute was used to induce knee pain and Visual Analogue Scale (VAS) was used to measure the pain intensity. Assessments were performed at baseline, Days 5 and 7. One participant reported dyspepsia of mild grade that resolved on its own. When compared to baseline, time to initial discomfort significantly increased on Day-5 (Mean Difference [MD] = 30s, <i>p</i> = 0.016) and Day-7 (MD = 32s, <i>p</i> = 0.007). Whereas the maximum VAS score decreased with time and on Day-7 and it was significantly low when compared with baseline (MD = -0.93, <i>p</i> = 0.008). In summary, Turmacin® supplements given at a dose of 2 g/day was safe and tolerable. Similar to the previous study with low dose Turmacin®, there was a significant increase in pain threshold and decrease in the maximum pain score post intervention.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and Efficacy of Moderately-High Dose Turmacin® (Turmerosaccharide >10% w/w) Supplementation on Joint Discomfort in Healthy Adults - A Pilot Proof-of-Concept Single Arm Study.\",\"authors\":\"Jeffrey Pradeep Raj, Shreeraam Venkatachalam, Rajkumar S Amaravati\",\"doi\":\"10.1080/19390211.2023.2176577\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Turmeric is well-known for its analgesic, anti-inflammatory and anti-arthritic properties but 69.4% of the turmeric rhizome contains Turmerosaccharides whose clinical benefit is still unexplored. Turmacin®/NR-INF-02 is an aqueous extract of Turmeric containing Turmerosaccharides (>10%w/w) with negligible curcuminoids. Previous study with low dose Turmacin® confirmed its safety and efficacy in alleviating induced knee pain in healthy volunteers. Hence, this study aimed to assess the safety and explore the efficacy of moderately high dose Turmacin®. It was an open-label, single-arm interventional trial conducted from August 2018 - January 2019 in a tertiary care teaching hospital. Turmacin® was administered for seven days to 15 healthy volunteers as four capsules of 500 mg each in the morning with food. The stair mill at a speed of 60 steps per minute was used to induce knee pain and Visual Analogue Scale (VAS) was used to measure the pain intensity. Assessments were performed at baseline, Days 5 and 7. One participant reported dyspepsia of mild grade that resolved on its own. When compared to baseline, time to initial discomfort significantly increased on Day-5 (Mean Difference [MD] = 30s, <i>p</i> = 0.016) and Day-7 (MD = 32s, <i>p</i> = 0.007). Whereas the maximum VAS score decreased with time and on Day-7 and it was significantly low when compared with baseline (MD = -0.93, <i>p</i> = 0.008). In summary, Turmacin® supplements given at a dose of 2 g/day was safe and tolerable. 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引用次数: 0
摘要
姜黄以其镇痛、抗炎和抗关节炎的特性而闻名,但69.4%的姜黄根茎中含有姜黄糖,其临床疗效尚未得到探索。Turmacin®/NR-INF-02是一种含有姜黄糖(>10%w/w)和姜黄素可忽略不计的姜黄水提取物。先前的研究证实了低剂量Turmacin®在健康志愿者中减轻膝关节疼痛的安全性和有效性。因此,本研究旨在评估中高剂量Turmacin®的安全性和疗效。这是一项开放标签、单臂介入试验,于2018年8月至2019年1月在一家三级护理教学医院进行。Turmacin®作为4粒胶囊,每粒500毫克,与食物一起在早晨给15名健康志愿者服用7天。采用速度为每分钟60步的楼梯磨床诱导膝关节疼痛,并采用视觉模拟量表(VAS)测量疼痛强度。在基线、第5天和第7天进行评估。一名参与者报告轻度消化不良自行消退。与基线相比,第5天(Mean Difference [MD] = 30s, p = 0.016)和第7天(MD = 32s, p = 0.007)出现初始不适的时间显著增加。而最大VAS评分随着时间的推移和第7天下降,与基线相比显著降低(MD = -0.93, p = 0.008)。综上所述,每天服用2g的Turmacin补充剂是安全且可耐受的。与先前低剂量Turmacin®的研究类似,干预后疼痛阈值显著升高,最大疼痛评分显著降低。
Safety and Efficacy of Moderately-High Dose Turmacin® (Turmerosaccharide >10% w/w) Supplementation on Joint Discomfort in Healthy Adults - A Pilot Proof-of-Concept Single Arm Study.
Turmeric is well-known for its analgesic, anti-inflammatory and anti-arthritic properties but 69.4% of the turmeric rhizome contains Turmerosaccharides whose clinical benefit is still unexplored. Turmacin®/NR-INF-02 is an aqueous extract of Turmeric containing Turmerosaccharides (>10%w/w) with negligible curcuminoids. Previous study with low dose Turmacin® confirmed its safety and efficacy in alleviating induced knee pain in healthy volunteers. Hence, this study aimed to assess the safety and explore the efficacy of moderately high dose Turmacin®. It was an open-label, single-arm interventional trial conducted from August 2018 - January 2019 in a tertiary care teaching hospital. Turmacin® was administered for seven days to 15 healthy volunteers as four capsules of 500 mg each in the morning with food. The stair mill at a speed of 60 steps per minute was used to induce knee pain and Visual Analogue Scale (VAS) was used to measure the pain intensity. Assessments were performed at baseline, Days 5 and 7. One participant reported dyspepsia of mild grade that resolved on its own. When compared to baseline, time to initial discomfort significantly increased on Day-5 (Mean Difference [MD] = 30s, p = 0.016) and Day-7 (MD = 32s, p = 0.007). Whereas the maximum VAS score decreased with time and on Day-7 and it was significantly low when compared with baseline (MD = -0.93, p = 0.008). In summary, Turmacin® supplements given at a dose of 2 g/day was safe and tolerable. Similar to the previous study with low dose Turmacin®, there was a significant increase in pain threshold and decrease in the maximum pain score post intervention.
期刊介绍:
The Journal of Dietary Supplements (formerly the Journal of Nutraceuticals, Functional & Medical Foods) has been retitled to reflect the bold departure from a traditional scientific journal presentation to a leading voice for anyone with a stake in dietary supplements. The journal addresses important issues that meet the broad range of interests from researchers, regulators, marketers, educators, and health professionals from academic, governmental, industry, healthcare, public health, and consumer education sectors. This vital tool not only presents scientific information but interprets it - helping you more readily pass it on to your students, patients, clients, or company.