Effectiveness of methylcobalamin and alpha lipoic acid in diabetic neuropathy.

Not Applicable

Recruiting

• Conditions: Diabetic neuropathy.; Autonomic neuropathy in endocrine and metabolic diseases; G99.0

• Registration Number: IRCT20221122056577N1
• Lead Sponsor: Abba Darou Teb Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Male or female patients with diabetes mellitus type 2 and having peripheral neuropathy symptoms with =2 neuropathic pain scale scores.
The age group must be between 18-80 years old.
Symptomatic conditions with neuropathic pain, numbness, tingling & burning sensation in the extremities for at least 1 month before enrolling in the study.
Consent and compliance with all aspects of the study protocol, methods, and providing data during follow up contact.

Exclusion Criteria

Presence of foot ulcer.
Presence of peripheral vascular disease (non-palpable foot pulses, intermittent claudication).
Patients who are contraindicated with Methylcobalamin, Alphalipoic acid, folic acid, or vitamin B6 and B1 usage.
Pregnant or lactating women.
Patients with a history or presence of Stroke, Alzheimer's Disease, Bell's Palsy, Parkinson's Disease, Epilepsy and Seizures, psychiatric and other neurological disorders.
Patients who are known cases of the kidney disorders.
Hypothyroidism.
Decompensated cirrhosis.
Patients who consume alcohol or have a history of alcohol dependency followed by any current use.
Current use or history of having received study investigational drugs or participated in any other clinical trial which ended in the preceding three months or is currently ongoing.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of diabetic neuropathy. Timepoint: Investigation of parameters would be performed throughout the treatment period followed by visit-I (baseline), visit-II (week 4), visit-III (week 8), and visit-IV (week 12). Method of measurement: Vibration perception thresholds (VPT) through Biothesiometer, Visual Analog Scale (VAS), and Neuropathic Pain Scale (NPS) would be used to assess the patients on all four visits.