AN OPEN RANDOMIZED TRIAL IN PRE-DIABETES EVALUATING EFFECTIVENESS OF ADD-ON PLANT EXTRACTS USED IN HOMEOPATHY AS MOTHER TINCTURES: A RESEARCH PROTOCOL

Shubhamoy Ghosh; Bhargab Chattopadhyay; Shukdeb Maiti; Munmun Koley; Shubhranil Saha; Abhijit Dutta

Volume : VIII, Issue : VIII, August - 2019

AN OPEN RANDOMIZED TRIAL IN PRE-DIABETES EVALUATING EFFECTIVENESS OF ADD-ON PLANT EXTRACTS USED IN HOMEOPATHY AS MOTHER TINCTURES: A RESEARCH PROTOCOL

Shubhamoy Ghosh, Bhargab Chattopadhyay, Shukdeb Maiti, Munmun Koley, Shubhranil Saha, Abhijit Dutta

Abstract :

Background: Pre–diabetes can be termed as at risk of developing diabetes. Targeting pre–diabetes in the population may be considered as having immense value in preventing much adversity of diabetes. Keeping this in mind we intend to evaluate the effectiveness of add–on plant extracts used in homeopathy as mother tinctures in pre–diabetes. Methods/Designs: In this open randomized trial evaluating effectiveness of add–on plant extracts used in homeopathy as mother tinctures on patients diagnosed with pre–diabetes will be randomized in 1:1 ratio to one of the two interventions– Individualized homoeopathy or mother tincture as an add–on to Individualized homoeopathy. The outcome measure are being used in this study, Fasting Blood Sugar (FBS), Post–Prandial Blood Sugar (PPBS), Glycated Haemoglobin (HbA1C) as primary and Revised Diabetes Symptom Checklist (DSC–R) as secondary, will be taken at baseline, after 3 months and 6 months. Trial will require 140 patients, keeping in mind 90% power, level of significance at 0.05 and 5% drop–out. All the collected data will be analysed on intention to treat approach following CONSORT guidelines. Discussion: This trial will evaluate the effectiveness data of add–on mother tincture therapy to individualized homoeopathy. Trial registration: CTRI/2018/08/015319