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

Sponsor
Vedic Lifesciences Pvt. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04504305
Collaborator
(none)
64
Enrollment
2
Locations
2
Arms
6.9
Actual Duration (Months)
32
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: NeuropAWAY
  • Other: Microcystalline cellulose
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 23, 2020
Actual Primary Completion Date :
Jan 7, 2021
Actual Study Completion Date :
Feb 18, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory. [42 days]

  2. effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index. [42 Days]

  3. effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 . [42 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stress Test Clinic Mumbai Maharashtra India 400047
2 Shantaee Mumbai Maharashtra India 400067

Sponsors and Collaborators

  • Vedic Lifesciences Pvt. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT04504305
Other Study ID Numbers:
  • VC/190403/NUEROPAWAY/PN
First Posted:
Aug 7, 2020
Last Update Posted:
Apr 8, 2021
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 8, 2021