A Randomized Controlled Trial to Assess the Effect of L-carnitine in Patients With Diabetic Peripheral Neuropathy to Relief Pain and Symptom Improvement

Phase 2

• Conditions: Patient Compliance
• Interventions: Drug: Levocarnitine

• Registration Number: NCT04145245
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes mellitus. The prevalence rate is approaching towards a peak throughout the world including Bangladesh. The current intervention used in peripheral neuropathy does not bring satisfactory result. Recent trial shows that L-carnitine is effective and safe in DPN. So it is expected that L-carnitine may produce better effect in compared to other medicine used previously for alleviation of DPN.

Detailed Description

: Diabetic peripheral neuropathy is one of the common complication of chronic diabetes mellitus, with a 30-50 % prevalence. Progressive development of pain, numbness in toes or feet and sensory motor disorders affects the patient's quality of life. The epidemic spread of the disease has raised concern among physicians and researchers. A variety of agents or medicines with potential effect have been studied to control development of peripheral neuropathy. The existing management are yet unsatisfactory. Recent studies have suggested that L-carnitine is potential to alleviate symptoms in patents with diabetic neuropathy. Previous trial also indicated the efficacy and safety of L-carnitine on diabetic neuropathy. This limitations have led to search for an effective and tolerable option by placebo controlled trial.The present study is an attempt to investigate the effects of carnitine on pain and symptom improvement of diabetic peripheral neuropathy.

Study Timeline

• Study Start: 2018-04-17
• Status Verified: 2019-10
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30
• Primary Completion: 2019-12-30
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

i. Clinically diagnosed diabetic patients who had been on stable antidiabetic therapy for 1 year ii.Age: 18 years to 70 years iii. Patients HbA1c level <10

Exclusion Criteria

i. Patient who are suffering from other causes of peripheral neuropathy for example chemotherapy and HIV patient, rheumatoid arthritis, SLE, alcololism, vitamin B12 deficiency etc ii. Lactating and pregnant women iii. Patients taking anticonvulsants, antidepressants, opoioids and other neuropathic pain medication agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention or group a	Levocarnitine	Diabetic neuropathy patients with antidiabetic therapy in addition with l-carnitine supplementation
Placebo or group b	Levocarnitine	Diabetic neuropathy patients with antidiabetic treatment in addition with placebo

Primary Outcome Measures

Name	Time	Method
VAS score	10 weeks	Alleviation of VAS Score of pain

Secondary Outcome Measures

Name	Time	Method
Improvement of neuropathic symptom	10 weeks	Alleviation of NSS and NDS of diabetic neuropathy

Trial Locations

Locations (1)

Pharmacology department,BSMMU.; 🇧🇩 Dhaka, Dhaka,Sahbagh, Bangladesh