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.
1 other identifier
interventional
64
1 country
2
Brief Summary
this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2020
CompletedFirst Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2021
CompletedApril 8, 2021
August 1, 2020
6 months
August 4, 2020
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Neuropaway
ACTIVE COMPARATORMicrocystalline cellulose
PLACEBO COMPARATORInterventions
2 capsules thrice daily to be taken half an hour prior to meal.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Stress Test Clinic
Mumbai, Maharashtra, 400047, India
Shantaee
Mumbai, Maharashtra, 400067, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 7, 2020
Study Start
July 23, 2020
Primary Completion
January 7, 2021
Study Completion
February 18, 2021
Last Updated
April 8, 2021
Record last verified: 2020-08