Efficacy of homoeopathic treatment for diabetic distal symmetric polyneuropathy: A multicentric randomised double-blind placebo-controlled clinical trial

Abstract

Background: There are limitations in the management of Diabetic Distal Symmetric Polyneuropathy (DDSP) in conventional system but in Homoeopathy the research studies have shown positive results. These studies were not robust enough to prove the efficacy of individualized homoeopathy, thus this protocol has been developed to assess the efficacy of these individualized homoeopathic drugs in this disease. Material and Methods: It shall be a double blind randomised placebo controlled clinical trial. On the basis of earlier observational studies and repertorial anamnesis of DDSP symptoms, 15 homoeopathic medicines have been identified. The validated scales are being used for evaluating the outcomes post-intervention. The primary outcome is change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. The secondary outcomes include the changes in HbA1c, peripheral nerve conduction test, World Health Organization Quality Of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months post intervention. Discussion: Results from this trial will help to construct a strategy for treating the patients with DDSP and for improving the quality of life of diabetic patients. Trial Registration: Clinical Trial Registry - India: CTRI/2013/07/003818.