Back to resultsTo Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
Primary Purpose
Diabetic Neuropathies, Insomnia Due to Medical Condition
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
NeuropAWAY
Microcystalline cellulose
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies
Eligibility Criteria
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.
Sites / Locations
- Stress Test Clinic
- Shantaee
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Neuropaway
Microcystalline cellulose
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .
Full Information
NCT ID
NCT04504305
First Posted
August 4, 2020
Last Updated
April 6, 2021
Sponsor
Vedic Lifesciences Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04504305
Brief Title
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
February 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Insomnia Due to Medical Condition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuropaway
Arm Type
Active Comparator
Arm Title
Microcystalline cellulose
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
NeuropAWAY
Intervention Description
2 capsules thrice daily to be taken half an hour prior to meal.
Intervention Type
Other
Intervention Name(s)
Microcystalline cellulose
Intervention Description
2 capsules thrice daily to be taken half an hour prior to meal.
Primary Outcome Measure Information:
Title
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
Description
pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain
Time Frame
42 days
Secondary Outcome Measure Information:
Title
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.
Time Frame
42 days
Title
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.
Time Frame
42 Days
Title
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .
Time Frame
42 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Stress Test Clinic
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400047
Country
India
Facility Name
Shantaee
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400067
Country
India
12. IPD Sharing Statement
Learn more about this trial
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
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