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


Keywords


Pre-Diabetes, Mother tincture, Homoeopathy, Randomized trial

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