A PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFICACY OF GAYATRIADI YOGA VATI AS AN ADD ON INTERVENTION IN THE MANAGEMENT OF JATAJA PRAMEHA W.S.R. TO JUVENILE DIABETES IN CHILDREN

Background: Type 1 diabetes is a predominantly autoimmune (95%) or idiopathic (5%) disorder in which there is absolute insulin deficiency due to the destruction of pancreatic beta cells, the clinical manifestations of which occur once more than 80% of beta cells are destroyed.

Aim and Objective: To evaluate the efficacy of Gayatriadi Yoga Vati as an add on intervention in the management of Jataja Prameha. Materials and Methods: In this open labelled randomized placebo controlled clinical trial, 20 patients of Juvenile diabetes were enrolled and randomly divided into 2 groups: Group A (Gayatriadi Yoga Vati Trial) and Group B (Placebo Vati Control). 3 patients from this study were dropped out before the completion of intervention from Group B. The intervention period was 3 months and the follow up period was 1 month. Subjective assessment was carried out with the changes in the signs and symptoms of disease viz. polyphagia, polydipsia, polyuria, weight loss, fatigue and random body aches meanwhile objective assessment was carried out by comparing the changes in the values of laboratory investigations viz. FBS, PPBS, HbA1c and c peptide (in selected cases only). Sigmastat 3.5 software was used for analysis, with intra-group comparisons via Wilcoxon signed rank and paired t-tests, and inter-group via Mann-Whitney U and unpaired t-tests (significance at P<0.05).

Results: A statistically significant difference was found (p <0.05) in chief complaints viz. polyphagia, weakness and random body aches in Group A (GYV). No any objective parameters except injectable insulin dose (Grp A) showed statistically significant changes in both groups. On comparing the effect of therapy only tiredness showed statistically significant change.

Conclusion: Thus the null hypothesis (H0) is accepted and alternate hypothesis (H1) is rejected.