To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.

April 6, 2021 updated by: Vedic Lifesciences Pvt. Ltd.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400047
        • Stress Test Clinic
      • Mumbai, Maharashtra, India, 400067
        • Shantaee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and Females aged ≥ 40 and ≤ 65 years of age.
  • Participants with primary complaints of lower limb pain.
  • History of Diabetes mellitus for more than one year.
  • Participants with HbA1c ≥ 7.1 and ≤ 9.5%

Exclusion Criteria:

  • Diagnosed with severe cardiac disease
  • Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neuropaway
Other: NeuropAWAY
2 capsules thrice daily to be taken half an hour prior to meal.
Placebo Comparator: Microcystalline cellulose
Other: Microcystalline cellulose
2 capsules thrice daily to be taken half an hour prior to meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
42 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vedic Lifesciences Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Actual)

January 7, 2021

Study Completion (Actual)

February 18, 2021

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC/190403/NUEROPAWAY/PN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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