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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04504305

Enrollment

Registered

2020-08-07

Start date

2020-07-23

Completion date

2021-02-18

Last updated

2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies, Insomnia Due to Medical Condition

Brief summary

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

Interventions

OTHERNeuropAWAY

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

OTHERMicrocystalline cellulose

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Measure	Time frame
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 insomnia Severity index.	42 Days
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .	42 Days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026