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 effi cacy of individualized homoeopathy, thus this protocol has been developed to
assess the effi cacy 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 identifi ed. 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.
