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

What Was Tested

The trial (phase 2) is built around L-Carnitine.

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes mellitus.

The current intervention used in peripheral neuropathy does not bring satisfactory result.

It had two arms (groups): Intervention or group a (experimental) and Placebo or group b (placebo comparator).

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

Diabetic neuropathy patients with antidiabetic treatment in addition with placebo.

The registry classes the interventions as drug.

More on the Plan

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.

The existing management are yet unsatisfactory.

Who Took Part

104 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2018-04-17 with completion listed for 2019-12-30.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: VAS score (time frame: 10 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 104 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.