Comparative Evaluation of Effect of Asbi with Methylcobalamin and Pregablin in Diabetic Peripheral Neuropathy

Not Applicable

Conditions: Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Lead Sponsor: Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh

Recruitment & Eligibility

Inclusion Criteria

Clinical Diagnosed Patients of Diabetic Peripheral Neuropathy With Type 2 Diabetes Mellitus Through Toronto Clinical Neuropathy Score.

Fasting Blood Sugar Less than or equal to 150 mg/dl.

HbA1c Less than or equal to 8.

Vibration Perception Test upto Moderate Loss of Vibration Perception Evaluated by Diabetic Risk Profiler.

Washout Period of 20 Days for Patients Who Were Already Taking Any Drug for Neuropathy.

Patient Willing To Participate And Follow The Instructions.

Exclusion Criteria

Patient below 30 Years and Above 60 Years of Age.

Physiological Status: Pregnancy and Lactation.

Pathological Status: Cardiovascular, Renal, Hepatic Diseases and Thyroid Dysfunction.

Complications of Diabetes Other Than Diabetic Peripheral Neuropathy.

Clinically Suspected Case of Neuropathy Other Than Diabetes.

Patient Having Ischemic or Neuropathic Ulcer

Alcoholic Patients.

Patients Taking Neurotoxic Drugs.

Uncontrolled Cases of Diabetes Mellitus. HbA1c > 8.

Severe Loss of Vibration Sensation. Vibration Perception Test Value > 25 Volts.

Patients Who Refuse to Give Written Consent for the Study and Who Failed to Follow up.

Primary Outcome Measures

Name	Time	Method
Improvement in Vibration Perception Threshold Value <br/ ><br>Grade 0 No Loss of Vibration Perception-Complete Improvement <br/ ><br>Grade 1 Borderline Loss of Vibration Perception-Slight Improvement. <br/ ><br>Grade 2 Mild Loss of Vibration Perception-Partial Improvement. <br/ ><br>Grade 3 Moderate Loss Vibration Perception-No Improvement. <br/ ><br>Improvement in The Score For 10 Gram Monofilament. <br/ ><br>Timepoint: Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days). <br/ ><br>10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days).

Secondary Outcome Measures

Name	Time	Method
Improvement in the subjective parameters: <br/ ><br>Loss of light touch & temperature sensation <br/ ><br>Numbness & paraesthesia or both in feet & hands <br/ ><br>Pain symptoms including burning allodynia (contact pain).Timepoint: Assessment on 0, 15, 30, 45 & 60 days.