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

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-TZ0XXFY
Tanggal Input Registry : 18-12-2020

03-11-2020
Pain impact on daily life as measured by Visual Analogue Scale, Numeric Pain Scale, and Brief Pain Inventory measured at baseline, 4 weeks and 8 weeks after initial treatment
The secondary outcomes will be measured at baseline, 4 weeks and 8 weeks after initial treatment: 1. Physician global assessment 2. Patient global assessment 3. Total symptoms score in painful diabetic neuropathy 4. Quality of life 5. Safety profile
 
The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient: Randomized Clinical Trial
Eksperimental
This is a randomized clinical trial, active comparator, open label, controlled study. 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)
60
 

Inclusion Criteria:

1. Male or female 2. Adult age (>18 years old) 3. Diagnosed as painful diabetic neuropathy based on validated Diabetic Neuropathy Symptoms (DNS) and Diabetic Neuropathy Examination (DNE)

Exclusion Criteria:

1. Subjects with significant renal and liver problem 2. Subjects with known hypersensitivity to astaxanthin 3. Pregnancy and breastfeeding patients 4. Patients that enrolled any clinical trial within a month 5. Not competent enough in giving approval and answering questionnaires
 
128/KEPK-RSB/XII/20
Not Applicable
Not Applicable
06/PZ/XII/2020
Rizaldy Taslim Pinzon