Health Condition 1: E104- Type 1 diabetes mellitus with neurological complications
Conditions
Interventions
None listed
Sponsors
LYBL Healthcare Technology India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with diabetic neuropathy pain for at least 3 months Numeric Pain Rating Scale (NPRS) score less than 6 (mild to moderate) Michigan Neuropathy Screening Instrument score greater or equal to 7 on the questionnaire and greater or equal to 2 on the clinical portion of the screening Willingness to provide informed consent and comply with study procedures Stable baseline medication regimen for diabetes Controlled blood sugar values (HbA1c less than 8%)
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus Who are vegan Who are allergic to cow s milk Pregnant or breastfeeding women Uncontrolled diabetes mellitus (HbA1c greater than 8%) Increased lipid profile (Total Cholesterol greater than 250mg/dl) History of significant liver or kidney dysfunction 8. Who are on any other pain medications up to 1 month prior to enrollment Concurrent use of other Ayurvedic or herbal medications for neuropathic pain up to 1 month prior to enrollment Participation in another clinical trial within the past 30 days Severe psychiatric conditions or cognitive impairment Autoimmune conditions Steroids taken up to 1 month prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Numeric Pain Rating Scale (NPRS) scores from baseline to endpoint Improvement in Michigan Neuropathy Screening Instrument scores from baseline to endpoint Improvement in Nerve Conduction Study (in ten subjects)Timepoint: 0th day, 30th day, 60th day and 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| NOT APPLICABLETimepoint: NOT APPLICABLE | — |
Countries
India
Contacts
Public ContactDr Vinayak B Angadi
KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya
Outcome results
None listed