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The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

NCT04689984 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-30

No results posted yet for this study

Summary

Diabetes is one of the main health care problemsworldwide with 5% average increased number of cases every year. According to International Diabetes Federation the prevalence of people with diabetes reached the number of 425 million people in 2017 and estimated rising to 628 million by 2045. Painful Diabetic Neuropathy (PDN) is the most common complication of diabetes affecting 90% of the patients. The symptoms of PDN include numbness, burning, stabbing pain, paraesthesia or hyperesthesiaof both symmetrical limbthat could reduce the quality of life. Several studies have found several therapeutic options to cope with pain in the PDN, but the results are not as satisfactory due to the uncertain pathophysiology of the disease and the limitations of the drug that can be administered because of itspolypharmaceutical side effects. The causes of diabetic neuropathy not only include vascular and metabolic factors but also Reactive Oxygen Species.

There are several therapeutic options that can be administered such as glycemic index arrangement,foot care, symptomatic treatment, and predominantly pain therapy. According to guidelines, there are drugs therapy thatrecommended for PDN, among others, Gabapentin, Pregabalin and anticonvulsants until the pain subsides. Unfortunately, this treatment is only aimed at relieving the symptoms of existing pain but not working on existing pathophysiological mechanisms and fixing sensory deficits of neuropathy trials. Multi-target treatments is needed to attenuate neuronal inflammation, oxidative stress and apoptosis. Additional therapy can be an option to support healing and also the process of metabolic pathophysiology that occurs due to rising glycemic index in the body that causes the work of hexosamine pathway and trigger the formation of ROS and inflammation. There is evidence of research demonstrating the neuroprotective effects of Astaxanthin as oxidative, anti-inflammatory and anti-apoptotic agent. Not only that, Astaxanthin is also a good supplement addition with no toxic effects when consumed, as well as hydrophilic and also lipophilic nature which makes Astaxanthin can penetrate the BBB effectively.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

Standard therapy

Gabapentin, pregabalin, or amitriptyline

DRUG

Astaxanthin

Astaxanthin 6 mg tablet once daily

Sponsors & Collaborators

  • PT SOHO Global Health Tbk

    collaborator UNKNOWN

  • Duta Wacana Christian University

    lead OTHER

Principal Investigators

  • Rizaldy T Pinzon, MD, MSc, PhD · Duta Wacana Christian University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04689984 on ClinicalTrials.gov