To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
NCT ID: NCT04504305
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2020-07-23
2021-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neuropaway
NeuropAWAY
2 capsules thrice daily to be taken half an hour prior to meal.
Microcystalline cellulose
Microcystalline cellulose
2 capsules thrice daily to be taken half an hour prior to meal.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
65 Years
ALL
No
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Stress Test Clinic
Mumbai, Maharashtra, India
Shantaee
Mumbai, Maharashtra, India
Countries
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Other Identifiers
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VC/190403/NUEROPAWAY/PN
Identifier Type: -
Identifier Source: org_study_id
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