To Evaluate the Efficacy and Safety of HSK16149 With L-carnitine in Diabetic Peripheral Neuralgia Patients in China

What Was Tested

This registered not phased trial tested L-Carnitine.

The registry classes the interventions as drug.

Who Took Part

The registry lists 136 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Able to understand and voluntarily sign written informed consent;. Male or female over the age of 18 (including the threshold);. Diabetic peripheral neuralgia (DPNP) diagnosis;. The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and \< 90 mm during screening.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: 1\. peripheral neuropathy or pain unrelated to dpn that the investigator determined might confuse the dpnp assessment;; liver function: alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2.5 × upper limit of normal (uln); or total bilirubin (tbil) \> 1.5 × uln;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

It started in 2023-05-01 with completion listed for 2024-04-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 136 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.