Sanjay U Nipanikar, Kamalakar V Gajare, Vidyadhar G Vaidya, Amol B Kamthe, Sachin A Upasani, Vidyadhar S Kumbhar
{"title":"一项开放标签、随机、比较、平行组、多中心、前瞻性、干预性临床研究:评价“AHPL/AYTOP/0113”与“硫酸框架霉素乳膏”在急性伤口治疗中的疗效和安全性。","authors":"Sanjay U Nipanikar, Kamalakar V Gajare, Vidyadhar G Vaidya, Amol B Kamthe, Sachin A Upasani, Vidyadhar S Kumbhar","doi":"10.4103/asl.ASL_52_16","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds.</p><p><strong>Methodology: </strong>It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test.</p><p><strong>Results: </strong>Group-A subjects took significantly less (<i>P</i> < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better (<i>P</i> < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups.</p><p><strong>Conclusion: </strong>AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds.</p>","PeriodicalId":7805,"journal":{"name":"Ancient Science of Life","volume":"36 3","pages":"117-128"},"PeriodicalIF":0.0000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5566822/pdf/","citationCount":"3","resultStr":"{\"title\":\"An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of \\\"AHPL/AYTOP/0113\\\" in Comparison with \\\"Framycetin Sulphate Cream\\\" in Acute Wounds.\",\"authors\":\"Sanjay U Nipanikar, Kamalakar V Gajare, Vidyadhar G Vaidya, Amol B Kamthe, Sachin A Upasani, Vidyadhar S Kumbhar\",\"doi\":\"10.4103/asl.ASL_52_16\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds.</p><p><strong>Methodology: </strong>It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test.</p><p><strong>Results: </strong>Group-A subjects took significantly less (<i>P</i> < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better (<i>P</i> < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. 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引用次数: 3
摘要
目的:本研究的主要目的是评估AHPL/AYTOP/0113乳膏(一种多草药制剂)与硫酸Framycetin乳膏在急性伤口中的疗效和安全性。方法:采用开放标签、随机、比较、平行组、多中心临床研究。将47例受试者随机分为a组(AHPL/AYTOP/0113乳膏),42例受试者随机分为b组(硫酸Framycetin乳膏)。建议所有受试者应用研究药物,每日三次,持续21天或直至伤口完全愈合(以较早者为准)。随访时间分别为第2、4、7、10、14、17、21天或至创面完全愈合当天。描述定量测量的数据以mean±SD表示。代表分类数据的变量比较采用卡方检验。结果:a组创面愈合时间(平均)7.77 d显著少于b组创面愈合时间(平均)9.87 d (P < 0.05)。研究结束时,a组平均创面面积、创面愈合参数及创面相关疼痛均优于b组,差异有统计学意义(P < 0.05)。两组患者均表现出良好的总体疗效和耐受性。两组受试者均未发现不良事件或药物不良反应。结论:AHPL/AYTOP/0113乳膏对急性伤口的愈合效果优于硫酸弗拉米霉素乳膏。
An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of "AHPL/AYTOP/0113" in Comparison with "Framycetin Sulphate Cream" in Acute Wounds.
Objectives: The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds.
Methodology: It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test.
Results: Group-A subjects took significantly less (P < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better (P < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups.
Conclusion: AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds.