Health Condition 1: E134- Other specified diabetes mellituswith neurological complications
Conditions
Interventions
Intervention1: Alpha Lipoid Acid , Cynacobalamin ,Folic Acid , Inositol , Chromium picolinate , Pyridoxine hydrochloride , Lutein , Zinc Oxide: Alpha Lipoid Acid -200mg
Cynacobalamin -1.5mcg
Folic Aci
Sponsors
NARNE KRISHNA GEETHA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 30 to 75 years 2. Patients with DPN based on their history and complaints were subjected to clinical examination and monofilament testing along with Michigan Neuropathy Screening Instrument (MNSI) 3. Patients with Type 2 DM with glycosylated hemoglobin [HbA1c] ranging between 6.5% and 10.0% 4. Patients with painful DPN ranging from 1 month to 5 years. 5. Patients who provided informed consent
Exclusion criteria
Exclusion criteria: 1. Type 2 diabetes mellitus patients, diagnosed in past 1 year were excluded from the study 2. Patients with type 1 diabetes 3. Patients with any history of hypersensitivity reactions to pregabalin or nutraceuticals to be used in the study population. 4. Patients with hyperthyroidism, hypothyroidism, acromegaly, and Cushing’ syndrome 5. Patients with acute complications of Type 2 diabetes mellitus within the period of 6 months 6. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Score for PainTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression Change scaleTimepoint: 12 weeks;Mean Daily Sleep Interference scoreTimepoint: 12 weeks;Patient Global Impression Change scaleTimepoint: 12 weeks;Visual Analogue Score for PainTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr M Sathish Kumar
Saveetha medical college and hospital
Outcome results
None listed