A Comparison Between Non-steroid Anti-inflammatory Drugs and Its Combination with Eperisone hydrochloride in Acute Non-Spesific Back Pain
Tahapan Penelitian : Initial
Sponsor:
Duta Wacana Christian University School of Medicine, Yogyakarta, Indonesia
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-OB1RAKC
Tanggal Input Registry : 01-10-2019
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 07-10-2019 |
| Outcome Primer | Visual Analog Scale (VAS) |
| Outcome Skunder | Finger to Floor Distance (FFD), Modified Global Assessment of Functioning - Revised (mGAF-R), adverse event |
| Descriptive Information | |
| Judul Penelitian Popular | A Comparison Between Non-steroid Anti-inflammatory Drugs and Its Combination with Eperisone hydrochloride in Acute Non-Spesific Back Pain |
| Judul Penelitian Ilmiah | A Comparison Between Non-steroid Anti-inflammatory Drugs and Its Combination with Eperisone hydrochloride in Patients with Acute Non-Spesific Back Pain with Muscle Spasm |
| Jenis Penelitian | Interventional |
| Intervensi | There are 2 groups of subjects. First group will receive a combination of eperisone hydrochloride and ibuprofen, whereas second group will only receive ibuprofen. We use 50 mg of eperisone hydrochloride taken three times per day and 400 mg of ibuprofen taken two times per day. Each medication must be taken every day for 4 weeks. Each subject will also receive 500 mg of paracetamol as a rescue medication. |
| Jumlah Subyek Penelitian | 100 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: The inclusion criteria i.e.: a) male or female; b) age > 18 years old; c) willing to join this study and sign an informed consent form, d) has a low back pain with muscle spasm within 7 days.Exclusion Criteria: The exclusion ciretria i.e.: a) patients with a history of hypersensitivity to eperisone hydrochloride and/or ibuprofen; b) patients with low back pain due to other causes such as: malignancy, infection, abnormality of metabolism, hip osteoarthritis, referred pain from other organ, etc.; c) patients with a history of peptic ulcer, gastrointestinal bleeding, and severe dyspepsia; d) patients who received other pain treatment within 24 hours; e) patients who involved in other trial within 1 month before this study; f) patients with a significant liver, kidney, gastrointestinal, and cardiovascular disease; g) pregnant or has a pregnancy program; h) incompetent to give a consent and to answer the questionnaire. |
| Administrative Information | |
| Nomor Persetujuan Etik | 988/C.16/FK/2019 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 01/PZ/X/2019 |
| Contact Person | dr. Rosa De Lima Renita Sanyasi |