Anti-nociceptive Potential of Olmuv™ and its Safety Study through Skin Irritation Test

Abstract

Introduction: Topical applications in the pain management play an important role. A formulation Olmuv™ developed with herbs used in homeopathy is targeted to treat pains of different origins. Though its ingredients are well-established traditionally as well as scientifically, there was no study conducted on this formulation. Hence this study was conducted with the objective to find out the anti-nociceptive effects and safety (skin irritation potential) of OlmuvTM. 

Materials and methods: Anti-nociceptive effect of Olmuv™ was conducted in Swiss albino mice. Animals were divided into 4 groups viz. vehicle control, disease control, standard therapy and treatment dose (6ml/kg). Pain was induced by the administration of carrageenan 0.1ml (1% solution) in paw joint region of animals. Eddy’s hot plate and tail flick method of hot water and cold-water assay were used to evaluate by the response time in seconds. Statistical analysis was accomplished using one-way analysis of variance (ANOVA) considering p value <=0.05 as significant. Skin irritation study was conducted by applying approximately 0.04 ml of test product on the marked test site using a brush in healthy human volunteers. This was un-occluded till it dried off, post which the test site was occluded. Filter papers dipped in 1% Sodium Lauryl Sulphate (SLS) solution and 0.9% Isotonic Saline Solution were filled in another well of patch test chambers and both were applied occlusively on the back of participants by Clinical Research Associates at Hour 0. Evaluation was done after 48 hours with scoring for erythema and oedema from 1 to 4. 

Results: Anti-nociceptive study displayed that the increased mean response time in the treatment groups in comparison to control groups. The OlmuvTM group mean response time was found to be 14, 8.5 and 9.8 seconds, while vehicle control group mean response time was found to be 9.2, 3.8 and 3.8 seconds in Eddy’s hot plate, hot tail-flick and cold tail-flick methods respectively after 7 hours. It was found almost similar with the standard treatment group in Eddy’s hot plate and cold tail-flick methods and closer with the same in hot tail-flick method. Skin irritation test showed that the score for erythema and oedema for OlmuvTM was found to be lower than the positive and negative controls. The mean score of OlmuvTM, Isotonic Saline Solution and SLS solution were found to be 0.10, 0.07 and 3.06 respectively.