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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2020-02-28

Brief Summary

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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.

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Detailed Description

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: 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.

Conditions

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Patient Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional Group- Patients with carnitine in addition to antidiabetic therapy Control Group- Patients with placebo and antidiabetic therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

placebo controlled, double bind

Study Groups

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Intervention or group a

Diabetic neuropathy patients with antidiabetic therapy in addition with l-carnitine supplementation

Group Type EXPERIMENTAL

Levocarnitine

Intervention Type DRUG

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

Placebo or group b

Diabetic neuropathy patients with antidiabetic treatment in addition with placebo

Group Type PLACEBO_COMPARATOR

Levocarnitine

Intervention Type DRUG

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

Interventions

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Levocarnitine

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

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No