{"title":"一项开放标签临床研究评估“无瘤DS”改善便秘的安全性和有效性","authors":"Varuni BG","doi":"10.59793/ijcp.v34i2.454","DOIUrl":null,"url":null,"abstract":"Background: Constipation is a common gastrointestinal problem in the general population. Despite a plethora of well-established and safe treatment options, the improvement is not satisfactory for many patients. This has prompted interest in alternative therapeutic strategies for constipation. Methods: This open-label, non-comparative single-arm clinical study evaluated the efficacy and safety of the polyherbal formulation “Anuloma DS”, 1 tablet daily at bedtime, in improving bowel movements in 30 adult patients with functional constipation. Patients were evaluated at baseline (Visit 1, Day 0) and follow-ups during Visit 2 (Day 7 ± 2), Visit 3 (Day 14 ± 2) and Visit 4 (End of the Study) at Day 30 ± 2. Results: There was a significant increase in the mean of spontaneous bowel movement every week from day 7 to days 14 and 30. All constipation symptoms such as abdominal bloating (aadmana), abdominal pain/discomfort (aanaha), feeling of incomplete evacuation and straining during passing stool improved significantly as did the SGA and the PGA scores. Conclusion: Anuloma DS is highly effective for the treatment of chronic functional constipation. No treatment-related side effects were reported by the study participants.","PeriodicalId":134500,"journal":{"name":"Indian Journal Of Clinical Practice","volume":"15 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"An Open-labeled Clinical Study to Evaluate the Safety and Efficacy of “Anuloma DS” in Improving Constipation\",\"authors\":\"Varuni BG\",\"doi\":\"10.59793/ijcp.v34i2.454\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: Constipation is a common gastrointestinal problem in the general population. Despite a plethora of well-established and safe treatment options, the improvement is not satisfactory for many patients. This has prompted interest in alternative therapeutic strategies for constipation. Methods: This open-label, non-comparative single-arm clinical study evaluated the efficacy and safety of the polyherbal formulation “Anuloma DS”, 1 tablet daily at bedtime, in improving bowel movements in 30 adult patients with functional constipation. Patients were evaluated at baseline (Visit 1, Day 0) and follow-ups during Visit 2 (Day 7 ± 2), Visit 3 (Day 14 ± 2) and Visit 4 (End of the Study) at Day 30 ± 2. Results: There was a significant increase in the mean of spontaneous bowel movement every week from day 7 to days 14 and 30. All constipation symptoms such as abdominal bloating (aadmana), abdominal pain/discomfort (aanaha), feeling of incomplete evacuation and straining during passing stool improved significantly as did the SGA and the PGA scores. Conclusion: Anuloma DS is highly effective for the treatment of chronic functional constipation. No treatment-related side effects were reported by the study participants.\",\"PeriodicalId\":134500,\"journal\":{\"name\":\"Indian Journal Of Clinical Practice\",\"volume\":\"15 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-07-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian Journal Of Clinical Practice\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.59793/ijcp.v34i2.454\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal Of Clinical Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.59793/ijcp.v34i2.454","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
An Open-labeled Clinical Study to Evaluate the Safety and Efficacy of “Anuloma DS” in Improving Constipation
Background: Constipation is a common gastrointestinal problem in the general population. Despite a plethora of well-established and safe treatment options, the improvement is not satisfactory for many patients. This has prompted interest in alternative therapeutic strategies for constipation. Methods: This open-label, non-comparative single-arm clinical study evaluated the efficacy and safety of the polyherbal formulation “Anuloma DS”, 1 tablet daily at bedtime, in improving bowel movements in 30 adult patients with functional constipation. Patients were evaluated at baseline (Visit 1, Day 0) and follow-ups during Visit 2 (Day 7 ± 2), Visit 3 (Day 14 ± 2) and Visit 4 (End of the Study) at Day 30 ± 2. Results: There was a significant increase in the mean of spontaneous bowel movement every week from day 7 to days 14 and 30. All constipation symptoms such as abdominal bloating (aadmana), abdominal pain/discomfort (aanaha), feeling of incomplete evacuation and straining during passing stool improved significantly as did the SGA and the PGA scores. Conclusion: Anuloma DS is highly effective for the treatment of chronic functional constipation. No treatment-related side effects were reported by the study participants.