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NCT04145245 Clinical Trial

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

Patient Compliance Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04145245
Other study ID # BSMMU/2019/3936
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 17, 2018
Est. completion date February 28, 2020

Study information
Verified date October 2019
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact Farhana Haque, MBBS
Phone 01734342464
Email farhanahaque857@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 104
Est. completion date February 28, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Levocarnitine
Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks

Locations
Country Name City State
Bangladesh Pharmacology department,BSMMU. Dhaka Dhaka,Sahbagh

Sponsors (1)
Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS score Alleviation of VAS Score of pain 10 weeks
Secondary Improvement of neuropathic symptom Alleviation of NSS and NDS of diabetic neuropathy 10 weeks
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