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

Vedic Lifesciences

Status: Completed

Conditions: Insomnia Due to Medical Condition; Diabetic Neuropathies

Treatments: Other: Microcystalline cellulose; Other: NeuropAWAY

Study type: Interventional

Funder types: Industry

Identifiers

NCT04504305

VC/190403/NUEROPAWAY/PN

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Neuropaway

Active Comparator group

Treatment:

Other: NeuropAWAY

Microcystalline cellulose

Placebo Comparator group

Treatment:

Other: Microcystalline cellulose