Randomized controlled trial to evaluate the efficacy of Laghumanjisthadi kashaya and Mahatrinaka Taila in the management of Vicharchika W.S.R to Eczema

The skin is the largest organ of the human body which is related to visual clinical speciality. skin is envelop of internal structure, which protects us against mechanical, chemical and biological hazards.  Now a  days, a Gradual increase in the prevalence of Vicharchika (Eczema) has been observed at general OPD level. The whole world is turning towards Ayurveda. Ayurveda has a lot to offer in this regard. so as vaidhya it’s our duty to help society as much as we can do. So that’s why vicharchika is chosen as a topic for research. Vicharchika has been correlated with eczema which has tendency of exacerbation and follows a chronic relapsing & remitting course.  So it is the need of the hour to find out safe and cost effective medicine for Vicharchika on a long term and here comes the role of Ayurveda. Therefore, keeping all these facts in mind, it has been decided to conduct a clinical study entitled as“A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF LAGHUMANJISHTHADI KASHAYA AND MAHA TRINAKA TAILA IN THE MANAGEMENT OF VICHARCHIKA W.S.R. TO ECZEMA.

Aim:  To evaluate the efficacy of “Laghumanjishthadi Kashaya and Mahatrinaka Taila in the management of Vicharchika w.s.r. to Eczema.

Objectives :

Primary objective: To study the effect of Laghumanjisthadi Kashaya and Mahatrinaka Taila on EASI score.

Secondary objectives: To study the effect of Laghumanjisthadi Kashaya and Mahatrinaka Taila in the Erythema, Dryness, Itching, Scaling, Discoloration, Oozing.

Null hypothesis[H0] : There is no difference in treatment outcome between the trial drug (“Laghumanjishthadi Kashaya and Mahatrinaka Tail”) and conventional first line drugs (Glycerin ointment & Tab Fexofenadine) in the management of Vicharchika w.s.r. to Eczema.

Alternative hypothesis[H1] :  There is difference in treatment outcome between trial drug( “Laghumanjishthadi Kashaya and Mahatrinaka Taila”) and conventional first line drugs (Glycerin ointment & tab Fexofenadine) in the management of Vicharchika w.s.r. to Eczema.

Study design : Phase of clinical study : Phase 2; Study type : Intervention, Single Centre, Randomized, Open label, Timing : Prospective,  Number of groups :two; Number of patients : 60 , Duration of study : 28 days( 4 weeks) .

The information gathered through observation will be used for statistical analysis in terms of Mean, Standard Deviation and Standard error (SE). For intra-group assessment, Wilcoxon matched – pairs signed Ranks test will be used for non – parametric data & for parametric data Paired ‘t-test’ will be used and results will be calculated. For inter-group comparisons, for the Non parametric variables Mann-Whitney Test will be used while for Parametric variables Unpaired ‘t’ Test will be used for statically analysis.