The Benefit of Add on Vitamin D or Vitamin B combination or Either for Painful Diabetic Neuropathy
Tahapan Penelitian : Initial
Sponsor:
Nothing to declare
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-WHMG3FX
Tanggal Input Registry : 03-02-2020
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 24-02-2020 |
| Outcome Primer | Visual Analogue Scale for pain intensity in 3 months after the medication administration |
| Outcome Skunder | BPI for physician global assessments, patients global assessments, total symptoms score in painful diabetic neuropathy, quality of life in 3 months after therapy and safety profile. |
| Descriptive Information | |
| Judul Penelitian Popular | The Benefit of Add on Vitamin D or Vitamin B combination or Either for Painful Diabetic Neuropathy |
| Judul Penelitian Ilmiah | he Benefit of Add on Vitamin D or Vitamin B combination or Either for Painful Diabetic Neuropathy |
| Jenis Penelitian | Interventional |
| Intervensi | Add on vitamin D (400 IU) per day to standard treatment (pregabalin, gabapentin, or amitryptilin) |
| Jumlah Subyek Penelitian | 64 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1.Male and female 2.> 18 years old 3.Diagnosed as painful diabetic neuropathy based on DNE and DNS examinationExclusion Criteria: 1.Subjects with significant renal and liver problem 2.Subjects with known hypersensitivity with vitamin D 3.Pregnancy and breastfeeding patients 4.Patients that enrolled any clinical trial within a month 5.Unwillingness to join the study |
| Administrative Information | |
| Nomor Persetujuan Etik | 1125/C.16/FK/2019 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 04/PZ/II/2020 |
| Contact Person | dr. Rizaldy Taslim Pinzon |