A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.

Vedic Lifesciences Pvt. Ltd.2 sites in 1 country64 target enrollmentJuly 23, 2020

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Neuropathies
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 64
Locations: 2
Primary Endpoint: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
Status: Completed
Last Updated: 5 years ago

this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.

Registry

clinicaltrials.gov

Start Date

July 23, 2020

End Date

February 18, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Diagnosed with severe cardiac disease
•Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥
•Type II DM with history of foot ulcers in the last six months prior to the study
•History of nerve damage not due to Painful Diabetic Neuropathy.

effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.

Time Frame: 42 days

pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain

effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.(42 days)
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .(42 Days)
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.(42 Days)