Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients – a study protocol

Abstract

Background In Ayurveda, disease causing biophysical energies (dosha) should be conquered at the initial stage. In the six stages of disease formation (Shatkriyakal), symptoms and signs can be seen in the localization stage (Sthansamshray), where amalgamation of vitiated biophysical energies with weak and susceptible tissues (dosha–dushya sammurchana) occur thereby manifesting disease. Echinops echinatus Roxb (Utkatar) is a traditionally used, classically described extra-pharmacopeial drug in Ayurveda, but less scientifically (clinically) explored medicinal herb. Few pre-clinical studies done on this plant revealed its anti-diabetic action but no clinical trial is noted till date. So, there is an urgent need to bridge the gap between the pre-clinical studies and empirical knowledge. Hence the present research work will be undertaken with the aim of exploring the anti-diabetic potential of Echinops echinatus Roxb (Utkatar) in Type II pre-diabetic patients. Aim and objectives Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatara) root ghana versus Nishaamalaki in pre-diabetic patients. Methods A total of 60 participants who meet the inclusion criteria will be chosen after conducting a drug analysis and divided into two groups of 30 each. Both Echinops echinatus Roxb (Utkatar) root ghana and Nishaamalaki will be administered twice daily for 30 days to groups A and B, respectively. After the intervention, assessment will be conducted on days 0, 1, 15, and 30. Day 45 will be reserved for follow-up. Results The observations of objective characteristics will be used to derive the results. Conclusion Based on statistical information derived from the data gathered, the study’s conclusion will be made.