Clinical Trials Logo
  1. Home
  2. Diabetic Neuropathies
  3. NCT04504305
  4. Details
NCT04504305 Clinical Trial

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

Diabetic Neuropathies Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04504305
Other study ID # VC/190403/NUEROPAWAY/PN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 23, 2020
Est. completion date February 18, 2021

Study information
Verified date August 2020
Source Vedic Lifesciences Pvt. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date February 18, 2021
Est. primary completion date January 7, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• NeuropAWAY
2 capsules thrice daily to be taken half an hour prior to meal.
• Microcystalline cellulose
2 capsules thrice daily to be taken half an hour prior to meal.

Locations
Country Name City State
India Shantaee Mumbai Maharashtra
India Stress Test Clinic Mumbai Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale. 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 effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory. 42 days
Secondary effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index. 42 Days
Secondary effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 . 42 Days
See also
  Status Clinical Trial Phase
Recruiting NCT05683106 - Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy N/A
Withdrawn NCT04106050 - Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy Phase 1
Completed NCT04088929 - The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy Phase 2
Completed NCT01939366 - Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves Phase 2
Withdrawn NCT00815932 - The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy N/A
Completed NCT01926522 - Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients N/A
Not yet recruiting NCT01180608 - Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain N/A
Completed NCT00760955 - Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Completed NCT00380913 - Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy Phase 4
Terminated NCT00756041 - Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Completed NCT05255497 - The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy N/A
Completed NCT06061237 - Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy N/A
Terminated NCT02915263 - The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes Phase 2
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT06373809 - Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy Early Phase 1
Completed NCT05968131 - Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy N/A
Completed NCT00282685 - Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy Phase 1
Completed NCT00135109 - Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy Phase 3
Completed NCT06292962 - Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain N/A
Completed NCT05058807 - Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy . N/A