PDF(Pubmed)
Abstract：
UNASSIGNED: Boswellin® Super is a standardized extract of Boswellia serrata Roxb gum resin, standardized to contain 30% 3-acetyl-11-keto-β-boswellic acid along with other β-boswellic acids (BSE). A randomized, double-blind, placebo-controlled clinical trial was conducted at two doses of BSE to understand its safety and efficacy in supporting joint health and improving mobility and symptoms of osteoarthritis (OA) of the knee.
UNASSIGNED: Based on the inclusion/exclusion criteria, 105 newly diagnosed participants with degenerative hypertrophy OA were recruited and randomized into Placebo, BSE-150 mg or BSE-300 mg (n = 35 in each group) to receive either 150 mg or 300 mg BSE or a placebo tablet twice a day for 90 days. All the participants were evaluated for pain and physical function using the standard tools including the Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne Functional Index (LFI), EuroQol- 5 Dimension (EQ-5D) quality of life, 6-min walk test at day 0, days 5, 30, 60 and 90 of treatment. Additionally, the circulating levels of inflammatory biomarkers, tumor necrosis factor-α (TNFα), high-sensitive C-reactive protein (hs-CRP), and interleukin-6 (IL-6) were evaluated. Safety was evaluated by blood biochemical, hematological analysis, urinary analyses and by monitoring adverse events throughout the study.
UNASSIGNED: Ninety-eight subjects completed the study. Improvements in pain scores were observed as early as 5 days after the start of the supplement in the BSE-150 and BSE-300 groups. By 90 days, the VAS pain score reduced by 45.3% and 61.9%, WOMAC- total score improved by 68.5% and 73.6% in the BSE-150 and BSE-300 groups respectively. WOMAC pain (70.2%, 73.9%, WOMAC stiffness (65.6%,68.9%), WOMAC function (68.8%,74.2%), LFI severity (50%,53.3%), decreased and EQ5D (56.9%, 62.9%) and distance walked in 6 minutes (21.2%, 21.9%) improved in the BSE-150 and BSE-300 groups in 90 days. Further, the levels of TNFα, hs-CRP, and IL-6 were found to decrease in the serum in BSE-supplemented participants. No significant adverse events were recorded during the study.
UNASSIGNED: The study confirms that Boswellin® Super can be used as a safe and effective supplement to support joint health and mobility in the management of osteoarthritis.
UNASSIGNED: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzU2Nzc=&Enc=&userName=CTRI, identifier CTRI/2022/11/047397.
UNASSIGNED: Based on the inclusion/exclusion criteria, 105 newly diagnosed participants with degenerative hypertrophy OA were recruited and randomized into Placebo, BSE-150 mg or BSE-300 mg (n = 35 in each group) to receive either 150 mg or 300 mg BSE or a placebo tablet twice a day for 90 days. All the participants were evaluated for pain and physical function using the standard tools including the Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne Functional Index (LFI), EuroQol- 5 Dimension (EQ-5D) quality of life, 6-min walk test at day 0, days 5, 30, 60 and 90 of treatment. Additionally, the circulating levels of inflammatory biomarkers, tumor necrosis factor-α (TNFα), high-sensitive C-reactive protein (hs-CRP), and interleukin-6 (IL-6) were evaluated. Safety was evaluated by blood biochemical, hematological analysis, urinary analyses and by monitoring adverse events throughout the study.
UNASSIGNED: Ninety-eight subjects completed the study. Improvements in pain scores were observed as early as 5 days after the start of the supplement in the BSE-150 and BSE-300 groups. By 90 days, the VAS pain score reduced by 45.3% and 61.9%, WOMAC- total score improved by 68.5% and 73.6% in the BSE-150 and BSE-300 groups respectively. WOMAC pain (70.2%, 73.9%, WOMAC stiffness (65.6%,68.9%), WOMAC function (68.8%,74.2%), LFI severity (50%,53.3%), decreased and EQ5D (56.9%, 62.9%) and distance walked in 6 minutes (21.2%, 21.9%) improved in the BSE-150 and BSE-300 groups in 90 days. Further, the levels of TNFα, hs-CRP, and IL-6 were found to decrease in the serum in BSE-supplemented participants. No significant adverse events were recorded during the study.
UNASSIGNED: The study confirms that Boswellin® Super can be used as a safe and effective supplement to support joint health and mobility in the management of osteoarthritis.
UNASSIGNED: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzU2Nzc=&Enc=&userName=CTRI, identifier CTRI/2022/11/047397.
摘要：
■Boswellin®Super是BoswelliaserrataRoxb胶树脂的标准化提取物，标准化为含有30％的3-乙酰基-11-酮-β-乳香酸以及其他β-乳香酸（BSE）。一个随机的，双盲,我们在两种剂量的BSE下进行了安慰剂对照临床试验,以了解其在支持关节健康,改善膝关节活动度和骨关节炎(OA)症状方面的安全性和有效性.
■根据纳入/排除标准，招募了105名新诊断为退行性肥大OA的参与者，并将其随机分配到安慰剂中，BSE-150mg或BSE-300mg(每组n=35)接受150mg或300mgBSE或安慰剂片剂,每天两次,持续90天。使用包括视觉模拟量表（VAS）在内的标准工具评估所有参与者的疼痛和身体功能，西安大略省和麦克马斯特大学骨关节炎指数（WOMAC），Lequesne功能指数(LFI)，EuroQol-5维（EQ-5D）生活质量，在治疗的第0天，第5天，第30天，第60天和第90天进行6分钟步行测试。此外,炎症生物标志物的循环水平，肿瘤坏死因子-α（TNFα），高敏C反应蛋白(hs-CRP),和白细胞介素-6（IL-6）进行评估。通过血液生化评估安全性，血液学分析,尿路分析和在整个研究过程中监测不良事件。
■98名受试者完成了研究。早在BSE-150和BSE-300组开始补充后5天就观察到疼痛评分的改善。到90天,VAS疼痛评分分别降低45.3%和61.9%,WOMAC总分在BSE-150和BSE-300组中分别提高了68.5%和73.6%。WOMAC疼痛（70.2%，73.9%,WOMAC刚度(65.6%，68.9%），WOMAC功能（68.8%，74.2%)，LFI严重程度（50%，53.3%），下降和EQ5D（56.9%，62.9％）和6分钟步行距离（21.2％，21.9%)在90天内BSE-150和BSE-300组提高。Further,TNFα的水平，hs-CRP,发现补充BSE的参与者的血清中IL-6降低。在研究期间没有记录到显著的不良事件。
■研究证实，Boswellin®Super可作为一种安全有效的补充剂，以支持骨关节炎的管理中的关节健康和活动能力。
■https://ctri。nic.在/临床试验/pmaindet2。php?EncHid=NzU2Nzc=&Enc=&userName=CTRI,标识符CTRI/2022/11/047397。
■根据纳入/排除标准，招募了105名新诊断为退行性肥大OA的参与者，并将其随机分配到安慰剂中，BSE-150mg或BSE-300mg(每组n=35)接受150mg或300mgBSE或安慰剂片剂,每天两次,持续90天。使用包括视觉模拟量表（VAS）在内的标准工具评估所有参与者的疼痛和身体功能，西安大略省和麦克马斯特大学骨关节炎指数（WOMAC），Lequesne功能指数(LFI)，EuroQol-5维（EQ-5D）生活质量，在治疗的第0天，第5天，第30天，第60天和第90天进行6分钟步行测试。此外,炎症生物标志物的循环水平，肿瘤坏死因子-α（TNFα），高敏C反应蛋白(hs-CRP),和白细胞介素-6（IL-6）进行评估。通过血液生化评估安全性，血液学分析,尿路分析和在整个研究过程中监测不良事件。
■98名受试者完成了研究。早在BSE-150和BSE-300组开始补充后5天就观察到疼痛评分的改善。到90天,VAS疼痛评分分别降低45.3%和61.9%,WOMAC总分在BSE-150和BSE-300组中分别提高了68.5%和73.6%。WOMAC疼痛（70.2%，73.9%,WOMAC刚度(65.6%，68.9%），WOMAC功能（68.8%，74.2%)，LFI严重程度（50%，53.3%），下降和EQ5D（56.9%，62.9％）和6分钟步行距离（21.2％，21.9%)在90天内BSE-150和BSE-300组提高。Further,TNFα的水平，hs-CRP,发现补充BSE的参与者的血清中IL-6降低。在研究期间没有记录到显著的不良事件。
■研究证实，Boswellin®Super可作为一种安全有效的补充剂，以支持骨关节炎的管理中的关节健康和活动能力。
■https://ctri。nic.在/临床试验/pmaindet2。php?EncHid=NzU2Nzc=&Enc=&userName=CTRI,标识符CTRI/2022/11/047397。
