Status:
UNKNOWN
The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
Lead Sponsor:
Duta Wacana Christian University
Collaborating Sponsors:
PT SOHO Global Health Tbk
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
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 re...
Detailed Description
Detailed Description: This was randomized clinical trial, active comparator, open label, controlled study from the period of November 2020 - November 2021 at Bethesda Hospital, Yogyakarta, Indonesia....
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04689984
Start Date
November 3 2020
End Date
November 1 2021
Last Update
December 30 2020
Active Locations (1)
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1
Bethesda Hospital Yogyakarta
Yogyakarta, Special Region of Yogyakarta, Indonesia, 55224