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

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.

Study Overview

• Status: Unknown
• Conditions: Patient Compliance
• Intervention / Treatment: Drug: Levocarnitine

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Farhana Haque, MBBS; Phone Number: 01734342464; Email: farhanahaque857@gmail.com
• Study Contact Backup: Name: Zesmin Dewan, PHD; Phone Number: 01712533169; Email: jfdewan@gmail.com

Study Locations

• Bangladesh
  • Dhaka,Sahbagh
    • Dhaka, Dhaka,Sahbagh, Bangladesh, 02
      • Recruiting
      • Pharmacology department,BSMMU.
      • Contact: Farhana Haque, MBBS; Phone Number: 01734342464; Email: farhanahaque857@gmail.com
      • Contact: Zesmin Dewan, PHD; Phone Number: 01712533169; Email: jfdewan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention or group a; Diabetic neuropathy patients with antidiabetic therapy in addition with l-carnitine supplementation	Drug: Levocarnitine; Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks; Other Names: Placebo
PLACEBO_COMPARATOR: Placebo or group b; Diabetic neuropathy patients with antidiabetic treatment in addition with placebo	Drug: Levocarnitine; Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	Alleviation of VAS Score of pain	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of neuropathic symptom	Alleviation of NSS and NDS of diabetic neuropathy	10 weeks

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Farhana Haque, MBBS, Resident, phase-B

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2018
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): February 28, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (ACTUAL): October 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: DPN, Levocarnitine
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: BSMMU/2019/3936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No