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OpenTrials
Completed

NCT Number: NCT04504305

To Assess the Efficacy of Investigational Product 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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Insomnia Due to Medical Condition Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shantaee, Mumbai, Maharashtra, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeuropAWAY

Other

2 capsules thrice daily to be taken half an hour prior to meal.

Microcystalline cellulose

Other

2 capsules thrice daily to be taken half an hour prior to meal.

Primary outcomes

  1. 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

Secondary outcomes

  1. effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.

    Time frame: 42 days

  2. effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.

    Time frame: 42 Days

  3. effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .

    Time frame: 42 Days

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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