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

A Clinical Study on Diabetic Peripheral Neuropathy and Comparative Evaluation of Asbi with Standard Control in its Management - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056046
Enrollment
60
Registered
2023-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Asbi: 2 Tablets Twice Daily For Two Months Control Intervention1: Methylcobalamine 750 Micrograms And Pregablin 75 Miligrams: One Tablet Once A Day For Two Maonths

Sponsors

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

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactTooba Hayat

Aligarh Muslim University

tabassum94tariq@gmail.com8218114385

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026