Pharmaceutical standardization of Mahatiktaka Ghrita & its comparative clinical study with external application in the management of Vicharchika (Eczema)

The main aim of study was to assess comparative efficacy of Mahatiktaka Ghrita administered internally along with external application of its ointment as that of only external application of its ointmentin the managementof Vicharchika. Clinical study has obtained permission from Institutional ethics committee (IEC NO-PGT/7/-A/Ethics/2022-23/2218/2.57) and also registered in Clinical Trial Registry of India (****CTRI/2023/05/052227).

Patients of 18 to 60 years of age fulfilling inclusion criteria were selected and enrolled in the study irrespective of their sex, religion, etc. from OPD and IPD of Rasashastra and Bhaishajya Kalpana department and referred from another OPDs, ITRA, Jamnagar. Detailed history was taken and physical examination was done on the basis of a special proforma incorporating signs and symptoms of the disease. Eight cardinal symptoms like Kandu, Vaivarnya, Rukshata, Daha, Pidika, Vidarana, Strava and Vedana. Special scoring pattern like EASI score*,* POEM Score and pruritus numerical scale included in the study. Investigations carried out were hematological (including TLC, DLC, Hb, ESR, Total RBC, AEC etc.) before, after treatment and at the end of follow-up and biochemical (RBS, LFT and RFT, Lipid profile) before treatment.

Observations:

Total 64 patients were enrolled in this trial with the purpose of treatment; Out of them, 61 patients were completed the full duration of treatment, while 2 patients from Group A and 1 patient from Group B left the treatment against medical advice at different stages.

Majority of the patients (35.94%) belongs to the age group of 41-50 years while 68.75% patients were males and 92.18% were Hindu. 90.62 % patients were married and 51.56% of the patients were educated up to primary, 42.18% were laborers, 42.18% patients were from lower middle class. 82.81% of patients were vegetarian. 46.87% of patients had addiction habits. 84.37% of patients had regular bowel habits. 85.93% of patients had normal sleep pattern. 51.56% of patients does only routine work. 51.56% of patients were having healthy weight. Maximum number of patients belonged to Pitta-Kapha and Vata-Pittaja Prakruti.Each enrolled patients in the study have Kandu and Vaivanyata over lesions (100%). 98.36%, 86.88%, 85.24% and 67.21% of patients were having complaints of Rukshata, Vidarana, Pidaka and Srava respectively. 95.31% of the patients reported gradual onset of the disease. 50% of patients were having a chronicity of more than 2 years.  89.06% and 25% of patients had lesions in exposed and closed parts of body respectively. 46.87% of patients had lesions on both extremities followed by 40.62% of patients had lesions only on lower limbs. 85.93% of patients had bilateral distribution of skin lesions. 95.31% of patients had localized skin lesions. 89.06% of patients had hyperpigmented lesions border wise. 89.06% of patients had plaque type of lesions. Maximum number of patients had pruritus numerical scale score between 7-10. 95.08% of patients had EASI scores between 1.1-7 for their lesion. 65.57% of patients had POEM Score between 8-16.

OVERALL EFFECT OF THE THERAPY

Out of 30 patients in group A, 46.67% patients showed marked positive response, 46.67% patients showed moderate improvement and 6.67% patients showed mild improvement. Out of 31 patients in Group B, 19.35 % patients showed marked positive response, 54.83% patients showed moderate improvement, 22.58% patients showed mild improvement and 3.22% patients had no improvement. None of the patients showed complete remission.

Group A showed 60%, 88.88%, 54.31%, 60.4%, 20%, 93.32% relief in symptoms like Kandu, Daha, Rukshata and Vidarana, Pidaka, Strava respectively after treatment. Group B showed 44.57%, 57.67%, 30.15%, 43.88%, 18.17%, 75.98% relief in symptoms like Kandu, Daha, Rukshata and Vidarana, Pidaka, Strava respectively. EASI Score shows 23.63%, 12.29% relief in Group A and Group B respectively after treatment. POEM score showed 38.84% and 28.29% relief in Group A and B respectively. Pruritus numerical scale showed 66.24% and 55.69% in Group A and B respectively after treatment. Both the groups showed statistically significant result through paired t test and Wilcoxon signed rank test.

Group A showed 52.37%, 85.17%, 41.42%, 35.43%, 20%, 93.32% relief in symptoms like Kandu, Daha, Rukshata, Vidarana, Pidaka, Strava respectively at the end of follow-up. Group B showed 36.62%, 46.15%, 19.19%, 24.41%, 18.17%, 80.01% relief in symptons like Kandu, Daha, Rukshata and Vidarana, Pidaka, Strava respectively at the end of follow-up. EASI Score showed 20.43%, 8.85% relief in Group A and B respectively at the end of follow-up. POEM Score showed 35.41%, 25.95% relief in Group A and B respectively at the end of follow-up. Pruritus numerical scale showed 65.38%, 53.16% in Group A and B respectively at the end of follow-up. All the scores showed statistically significant result in both group A and B through paired t test and Wilcoxon signed rank test.

The data showed significant difference on all subjective and objective criteria in between both the groups through Unpaired t test and Mann Whitney U test. On the basis of percentage relief, Group A showed better relief than Group B after treatment which was persisted at the end of follow-up.

Hence, null hypothesis is rejected and Alternate Hypothesis is accepted. Mahatiktaka Ghrita administered internally along with external application of its ointment is more effective than only external application of ointment of Mahatiktaka Ghrita in the management of Vicharchika.