Status:
COMPLETED
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Diabetic Neuropathies
Insomnia Due to Medical Condition
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04504305
Start Date
July 23 2020
End Date
February 18 2021
Last Update
April 8 2021
Active Locations (2)
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1
Stress Test Clinic
Mumbai, Maharashtra, India, 400047
2
Shantaee
Mumbai, Maharashtra, India, 400067