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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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