{"title":"Screening of herbal extracts for rapid effect on activity-induced knee joint discomfort: a randomized, placebo-controlled pilot study","authors":"Shalini Srivastava, R. Girandola","doi":"10.18203/2349-3259.ijct20240400","DOIUrl":null,"url":null,"abstract":"Background: A feasibility study was conducted to investigate the effect of different proprietary extracts on joint discomfort associated with repeated episodes of physical activity.\nMethods: A single-dose randomized, double-blind, placebo-controlled cross-over study was conducted in three phases with different extract combinations. Seventeen individuals aged 40-60 years with a history of knee joint pain aggravation on physical stress were randomized to receive the investigational product or the placebo in a 1:1 ratio. The primary outcome was the time taken to achieve meaningful pain relief (MPR) from baseline using a pain visual analog scale (VAS) compared to the placebo. The secondary outcomes were the pain intensity difference (PID) and joint discomfort at 1-, 2-, 3-, and 4-hours post-product administration and the time-weighted sum of pain intensity difference (SPID) over 4 hours compared to placebo.\nResults: Participants in two out of eight investigational product groups achieved MPR successfully. The proprietary combination ZV-E (consisting of Z. officinale and V. negundo) showed the fastest pain reduction with more than 50% of the participants achieving meaningful relief. The BS-ZP (consisting of B. serrata + Z. officinale + P. lanceolata) group also had more than 50% of participants reporting MPR at 4 hours post-IP administration. Subsequently, the SPID was found to be lowest in the participants of above stated groups.\nConclusions: The proprietary combination of Z. officinale and V. negundo extracts, 200 mg could be a promising lead to conduct a further trial to investigate its effect on joint pain.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"130 4","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18203/2349-3259.ijct20240400","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: A feasibility study was conducted to investigate the effect of different proprietary extracts on joint discomfort associated with repeated episodes of physical activity.
Methods: A single-dose randomized, double-blind, placebo-controlled cross-over study was conducted in three phases with different extract combinations. Seventeen individuals aged 40-60 years with a history of knee joint pain aggravation on physical stress were randomized to receive the investigational product or the placebo in a 1:1 ratio. The primary outcome was the time taken to achieve meaningful pain relief (MPR) from baseline using a pain visual analog scale (VAS) compared to the placebo. The secondary outcomes were the pain intensity difference (PID) and joint discomfort at 1-, 2-, 3-, and 4-hours post-product administration and the time-weighted sum of pain intensity difference (SPID) over 4 hours compared to placebo.
Results: Participants in two out of eight investigational product groups achieved MPR successfully. The proprietary combination ZV-E (consisting of Z. officinale and V. negundo) showed the fastest pain reduction with more than 50% of the participants achieving meaningful relief. The BS-ZP (consisting of B. serrata + Z. officinale + P. lanceolata) group also had more than 50% of participants reporting MPR at 4 hours post-IP administration. Subsequently, the SPID was found to be lowest in the participants of above stated groups.
Conclusions: The proprietary combination of Z. officinale and V. negundo extracts, 200 mg could be a promising lead to conduct a further trial to investigate its effect on joint pain.
背景:我们开展了一项可行性研究,以探讨不同的专有提取物对反复运动引起的关节不适的影响:我们开展了一项可行性研究,以调查不同的专利提取物对反复体育锻炼引起的关节不适的影响:方法:一项单剂量随机、双盲、安慰剂对照交叉研究分三个阶段进行,采用不同的提取物组合。17名年龄在40-60岁之间、有膝关节疼痛病史且在体力活动时疼痛加剧的患者按1:1的比例随机接受了研究产品或安慰剂。主要结果是与安慰剂相比,使用疼痛视觉模拟量表(VAS)从基线达到有意义的疼痛缓解(MPR)所需的时间。次要结果是与安慰剂相比,服用产品后1、2、3和4小时的疼痛强度差异(PID)和关节不适感,以及4小时内疼痛强度差异的时间加权总和(SPID):结果:八个研究产品组中有两个组的参与者成功实现了MPR。专有组合 ZV-E(由 Z. officinale 和 V. negundo 组成)的疼痛减轻速度最快,50% 以上的参与者获得了有意义的缓解。BS-ZP(由 B. serrata + Z. officinale + P. lanceolata 组成)组也有 50%以上的参与者在服用后 4 小时报告了 MPR。随后,发现上述组别的参与者的 SPID 最低:结论:200 毫克 Z. officinale 和 V. negundo 提取物的专有组合很有希望成为进一步研究其对关节疼痛影响的试验线索。