一项单一中心、开放标签、非随机的上市后监测研究,旨在测量 Petsaffa 片剂对便秘、胃胀气和胃酸患者的疗效和安全性

Shreya Verma, Amrish Verma, Jaspal Singh, Hasan Ali Ahmed, Dilip Kadam
{"title":"一项单一中心、开放标签、非随机的上市后监测研究,旨在测量 Petsaffa 片剂对便秘、胃胀气和胃酸患者的疗效和安全性","authors":"Shreya Verma, Amrish Verma, Jaspal Singh, Hasan Ali Ahmed, Dilip Kadam","doi":"10.47070/ijapr.v12i4.3207","DOIUrl":null,"url":null,"abstract":"Constipation, gas, and acidity are common gastrointestinal issues with a significant global prevalence. Traditional medicine systems like Ayurveda have long utilized medicinal plants to address these concerns. However, clinical validation of their efficacy in patients with constipation has been lacking. Objectives: This study aimed to assess the efficacy and safety of Petsaffa tablets, an Ayurvedic formulation containing various herbal ingredients, in relieving constipation, gas, and acidity. Methods: The study, conducted as a single-centric, open-label, non-randomized post-marketing surveillance study, involved 120 subjects with constipation. Subjects were evaluated using inclusion and exclusion criteria and provided Petsaffa tablets for a 14-day intervention. Various parameters, including bowel movement frequency, constipation scores, and subjective assessments, were measured. Vital signs, laboratory safety parameters, and adverse events were also monitored during the study period. Results: Petsaffa tablets significantly improved bowel movement frequency, constipation scores, and subjective symptoms related to constipation. Stool consistency and other associated symptoms such as acidity and gas were also reduced at the end of the study. None of the participants reported any adverse events, and safety parameters remained within normal limits during the study period. Conclusion: Petsaffa tablets offer a promising, safe, and effective alternative option for individuals with common gastrointestinal issues such as constipation, acidity, and gas.","PeriodicalId":13913,"journal":{"name":"International Journal of Ayurveda and Pharma Research","volume":"73 4","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Single Centric, Open-Label, Non-Randomized Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Petsaffa Tablets in Subjects Suffering From Constipation, Gas and Acidity\",\"authors\":\"Shreya Verma, Amrish Verma, Jaspal Singh, Hasan Ali Ahmed, Dilip Kadam\",\"doi\":\"10.47070/ijapr.v12i4.3207\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Constipation, gas, and acidity are common gastrointestinal issues with a significant global prevalence. Traditional medicine systems like Ayurveda have long utilized medicinal plants to address these concerns. However, clinical validation of their efficacy in patients with constipation has been lacking. Objectives: This study aimed to assess the efficacy and safety of Petsaffa tablets, an Ayurvedic formulation containing various herbal ingredients, in relieving constipation, gas, and acidity. Methods: The study, conducted as a single-centric, open-label, non-randomized post-marketing surveillance study, involved 120 subjects with constipation. Subjects were evaluated using inclusion and exclusion criteria and provided Petsaffa tablets for a 14-day intervention. Various parameters, including bowel movement frequency, constipation scores, and subjective assessments, were measured. Vital signs, laboratory safety parameters, and adverse events were also monitored during the study period. Results: Petsaffa tablets significantly improved bowel movement frequency, constipation scores, and subjective symptoms related to constipation. Stool consistency and other associated symptoms such as acidity and gas were also reduced at the end of the study. None of the participants reported any adverse events, and safety parameters remained within normal limits during the study period. Conclusion: Petsaffa tablets offer a promising, safe, and effective alternative option for individuals with common gastrointestinal issues such as constipation, acidity, and gas.\",\"PeriodicalId\":13913,\"journal\":{\"name\":\"International Journal of Ayurveda and Pharma Research\",\"volume\":\"73 4\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-05-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Ayurveda and Pharma Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.47070/ijapr.v12i4.3207\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Ayurveda and Pharma Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.47070/ijapr.v12i4.3207","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

便秘、胃胀气和胃酸是常见的肠胃问题,在全球的发病率很高。长期以来,阿育吠陀等传统医学体系一直利用药用植物来解决这些问题。然而,这些药用植物对便秘患者的疗效一直缺乏临床验证。研究目的本研究旨在评估含有多种草药成分的阿育吠陀制剂 Petsaffa 片剂在缓解便秘、胃气和胃酸方面的疗效和安全性。研究方法该研究是一项单一中心、开放标签、非随机的上市后监测研究,涉及 120 名便秘受试者。根据纳入和排除标准对受试者进行评估,并提供 Petsaffa 药片进行为期 14 天的干预。研究人员测量了各种参数,包括排便频率、便秘评分和主观评估。研究期间还对生命体征、实验室安全参数和不良事件进行了监测。研究结果Petsaffa 药片明显改善了排便频率、便秘评分以及与便秘有关的主观症状。在研究结束时,粪便稠度和其他相关症状(如胃酸和胃气)也有所减轻。在研究期间,所有参与者均未报告任何不良事件,各项安全指标均保持在正常范围内。结论Petsaffa 药片为便秘、胃酸和胃胀气等常见胃肠道问题患者提供了一种安全有效的替代选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Single Centric, Open-Label, Non-Randomized Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Petsaffa Tablets in Subjects Suffering From Constipation, Gas and Acidity
Constipation, gas, and acidity are common gastrointestinal issues with a significant global prevalence. Traditional medicine systems like Ayurveda have long utilized medicinal plants to address these concerns. However, clinical validation of their efficacy in patients with constipation has been lacking. Objectives: This study aimed to assess the efficacy and safety of Petsaffa tablets, an Ayurvedic formulation containing various herbal ingredients, in relieving constipation, gas, and acidity. Methods: The study, conducted as a single-centric, open-label, non-randomized post-marketing surveillance study, involved 120 subjects with constipation. Subjects were evaluated using inclusion and exclusion criteria and provided Petsaffa tablets for a 14-day intervention. Various parameters, including bowel movement frequency, constipation scores, and subjective assessments, were measured. Vital signs, laboratory safety parameters, and adverse events were also monitored during the study period. Results: Petsaffa tablets significantly improved bowel movement frequency, constipation scores, and subjective symptoms related to constipation. Stool consistency and other associated symptoms such as acidity and gas were also reduced at the end of the study. None of the participants reported any adverse events, and safety parameters remained within normal limits during the study period. Conclusion: Petsaffa tablets offer a promising, safe, and effective alternative option for individuals with common gastrointestinal issues such as constipation, acidity, and gas.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信