The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-LYY8GNT
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 Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient: Randomized Clinical Trial
Interventional
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 vitamin B combination (vitamin B1 100 mg, vitamin B6 200 mg, and vitamin B12 200 mcg) 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 vitamin B combination 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
 
127/KEPK-RSB/XII/20
07/PZ/XII/2020
Rizaldy Taslim Pinzon