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

Not Applicable

Completed

• Conditions: Diabetic Neuropathies; Insomnia Due to Medical Condition
• Interventions: Other: Microcystalline cellulose; Other: NeuropAWAY

• Registration Number: NCT04504305
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-23
• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-07
• Primary Completion: 2021-01-07
• Study Completion: 2021-02-18
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microcystalline cellulose	Microcystalline cellulose	-
Neuropaway	NeuropAWAY	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Stress Test Clinic; 🇮🇳 Mumbai, Maharashtra, India

Shantaee; 🇮🇳 Mumbai, Maharashtra, India