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ORIGINAL ARTICLE
Year : 2017  |  Volume : 36  |  Issue : 3  |  Page : 117-128

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


1 Department of R and D, Ari Healthcare Private Limited, Pune, Maharashtra, India
2 Department of Shalya Tantra, Sumatibhai Shah Ayurved Mahavidyalaya, Pune, Maharashtra, India
3 Department of Surgery, Lokmanya Medical Research Centre, Chinchwad, Pune, Maharashtra, India
4 Department of OPD, Kamthe Hospital, Pune, Maharashtra, India
5 Department of Medical Services, R and D Center, Ari Healthcare Private Limited, Pune, Maharashtra, India
6 Department of Clinical Trial, Lokmanya Medical Research Centre, Chinchwad, Pune, Maharashtra, India

Correspondence Address:
Sanjay U Nipanikar
R and D Center, Ari Healthcare Private Limited, Unit No. 401, International Biotech Park, BTS 2 Building, Chrysalis Enclave, 4th Floor, Plot No. 2A, MIDC Phase II, Hinjewadi, Pune - 411 057, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/asl.ASL_52_16

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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.


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