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

NCT04689984 | Unknown Phase 2

• 1 other identifier: ASTAXANTHIN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Astaxanthin; Standard therapy; Neuropathy; Diabetic neuropathy

Outcome Measures

Primary Outcomes (6)

• Improvement in Visual Analogue Scale (VAS) at week 4

  Change in pain impact on daily life as measured by Visual Analogue Scale (VAS) from its baseline value. Visual analogue scale is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100). The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  4 weeks after treatment initiation

• Improvement in Visual Analogue Scale (VAS) at week 8

  Change in pain impact on daily life as measured by Visual Analogue Scale (VAS) from its baseline and week 4 value. Visual analogue scale is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100). The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  8 weeks after treatment initiation

• Improvement in Numeric Pain Scale at week 4

  Change in pain impact on daily life as measured by Numeric Pain Scale from its baseline value. Numeric pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.

  4 weeks after treatment initiation

• Improvement in Numeric Pain Scale at week 8

  Change in pain impact on daily life as measured by Numeric Pain Scale from its baseline and week 4 value. Numeric pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.

  8 weeks after treatment initiation

• Improvement in Brief Pain inventory at week 4

  Change in pain impact on daily life as measured by Brief Pain Inventory from its baseline value. The Brief Pain Inventory evaluates a patient's pain experience through a number of different scales. There are line drawings of the front and back of a human body on which patients mark the location of their pain. Patients are asked to list the treatments or medications that they are using and how much relief they have provided in the past 24 hours. In addition, patients fill out 11 different numeric rating scale that ask about pain intensity (ranging from 0 to 10) and the effect of the pain on their ability to function during various activities of daily living. A higher score indicates greater pain intensity.

  4 weeks after treatment initiation

• Improvement in Brief Pain inventory at week 8

  Change in pain impact on daily life as measured by Brief Pain Inventory from its baseline and week 4 value. The Brief Pain Inventory evaluates a patient's pain experience through a number of different scales. There are line drawings of the front and back of a human body on which patients mark the location of their pain. Patients are asked to list the treatments or medications that they are using and how much relief they have provided in the past 24 hours. In addition, patients fill out 11 different numeric rating scale that ask about pain intensity (ranging from 0 to 10) and the effect of the pain on their ability to function during various activities of daily living. A higher score indicates greater pain intensity.

  8 weeks after treatment initiation

Study Arms (2)

Experimental Group

EXPERIMENTAL

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline and astaxanthin 6 mg tablet once daily (experimental group).

Drug: Standard therapy; Drug: Astaxanthin

Control Group

ACTIVE COMPARATOR

Receive standard therapy consists of gabapentin, pregabalin, or amitriptyline.

Drug: Standard therapy

Interventions

Standard therapy DRUG

Gabapentin, pregabalin, or amitriptyline

Control Group; Experimental Group

Astaxanthin DRUG

Astaxanthin 6 mg tablet once daily

Experimental Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Adult age (\>18 years old)
• Diagnosed as painful diabetic neuropathy based on validated Diabetic Neuropathy Symptoms (DNS) and Diabetic Neuropathy Examination (DNE)

You may not qualify if:

• Subjects with significant renal and liver problem
• Subjects with known hypersensitivity to astaxanthin
• Pregnancy and breastfeeding patients
• Patients that enrolled any clinical trial within a month
• Not competent enough in giving approval and answering questionnaires

Sponsors & Collaborators

• Duta Wacana Christian University: lead
• PT SOHO Global Health Tbk: collaborator

Study Sites (1)

Bethesda Hospital Yogyakarta

Yogyakarta, Special Region of Yogyakarta, 55224, Indonesia

RECRUITING

Related Publications (9)

• Fakhri S, Aneva IY, Farzaei MH, Sobarzo-Sanchez E. The Neuroprotective Effects of Astaxanthin: Therapeutic Targets and Clinical Perspective. Molecules. 2019 Jul 20;24(14):2640. doi: 10.3390/molecules24142640.

  PMID: 31330843 BACKGROUND

• Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.

  PMID: 29709457 BACKGROUND

• Javed S, Alam U, Malik RA. Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):63-83. doi: 10.1900/RDS.2015.12.63. Epub 2015 Aug 10.

  PMID: 26676662 BACKGROUND

• Juster-Switlyk K, Smith AG. Updates in diabetic peripheral neuropathy. F1000Res. 2016 Apr 25;5:F1000 Faculty Rev-738. doi: 10.12688/f1000research.7898.1. eCollection 2016.

  PMID: 27158461 BACKGROUND

• Kaur S, Pandhi P, Dutta P. Painful diabetic neuropathy: an update. Ann Neurosci. 2011 Oct;18(4):168-75. doi: 10.5214/ans.0972-7531.1118409.

  PMID: 25205950 BACKGROUND

• Rosenberger DC, Blechschmidt V, Timmerman H, Wolff A, Treede RD. Challenges of neuropathic pain: focus on diabetic neuropathy. J Neural Transm (Vienna). 2020 Apr;127(4):589-624. doi: 10.1007/s00702-020-02145-7. Epub 2020 Feb 8.

  PMID: 32036431 BACKGROUND

• Schreiber AK, Nones CF, Reis RC, Chichorro JG, Cunha JM. Diabetic neuropathic pain: Physiopathology and treatment. World J Diabetes. 2015 Apr 15;6(3):432-44. doi: 10.4239/wjd.v6.i3.432.

  PMID: 25897354 BACKGROUND

• Snyder MJ, Gibbs LM, Lindsay TJ. Treating Painful Diabetic Peripheral Neuropathy: An Update. Am Fam Physician. 2016 Aug 1;94(3):227-34.

  PMID: 27479625 BACKGROUND

• Wu H, Niu H, Shao A, Wu C, Dixon BJ, Zhang J, Yang S, Wang Y. Astaxanthin as a Potential Neuroprotective Agent for Neurological Diseases. Mar Drugs. 2015 Sep 11;13(9):5750-66. doi: 10.3390/md13095750.

  PMID: 26378548 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Standard of Care; astaxanthine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rizaldy T Pinzon, MD, MSc, PhD

  Duta Wacana Christian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rizaldy T Pinzon, MD, MSc, PhD

CONTACT

+62 81294638229; drpinzon17@gmail.com

Vanessa Veronica, BM

CONTACT

+62 89605559529; vanessaveronica73@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Neurologist

Model Details: Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and astaxanthin 6 mg tablet once daily (experimental group).

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 30, 2020
• Study Start: November 3, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)