Clinical trial NCT04145245: A Randomized Controlled Trial to Assess the Effect of L-carnitine in Patients With Diabetic Peripheral Neuropathy to Relief Pain and Symptom Improvement
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Patient Compliance
Keywords: DPN, Levocarnitine
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional Group- Patients with carnitine in addition to antidiabetic therapy Control Group- Patients with placebo and antidiabetic therapy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS score
timeFrame: 10 weeks
Secondary outcomes:
measure: Improvement of neuropathic symptom
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Pharmacology department,BSMMU.
state: Dhaka,Sahbagh
Study officials:
affiliation: Resident, phase-B
name: Farhana Haque, MBBS
role: PRINCIPAL_INVESTIGATOR
References: