Randomized placebo controlled clinical trial of unani herbo-mineral cream to evaluate its topical effects on acne vulgaris

ABSTRACT

A controlled, randomized single blind clinical trial was conducted as per GCP [Good Clinical Practice] Guidelines for the duration of two months on human individuals suffering from Acne vulgaris. The patients were divided into two groups, i e control group treated topically with only cream base and the test group treated topically with the Unani Herbo-Mineral Cream [UHC]. The effects of the UHC were scientifically evaluated in human beings in Acne vulgaris. The assessment of the severity of Acne vulgaris in the control and test groups were made by the "Investigators Global Acne Severity Score". The statistical analysis of the results of severity of Acne vulgaris in the control and test groups was made for the total duration of treatment. Within group comparisons and inter group comparisons were made using ANOVA and paired 't' test respectively. Within group and inter group comparison in the control group shows that the effect of only cream base did not show any significant improvement in the Acne vulgaris of the patients of control group. On the other hand, the within group and inter group comparisons in the test group showed that the differences of the results at each stage of the treatment were very significant The clinical study shows that the test drug 'UHC' has been proved safe and effective in the treatment of Acne vulgaris in the test group in comparison to the control group