Acute low back pain patient acute Low Back Pain (LBP) anti-
Conditions
Interventions
Ayurved Siriraj Sahatsatara recipe (AVS023) is a poly-
herbal formula used in Thai traditional medicine,Ibuprofen is an non-
steroidal anti-
inflammatory drugs (NSAIDs)
Experimental Drug,Active Comparator Drug
AVS023,Ibuprofen
Sponsors
Faculty of Medicine Siriraj Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18–65 years, who diagnosed with nonspecific acute LBP. 2. The eligible patients had moderate to severe acute LBP at baseline (score ≥ 4 on an 11-point numerical rating scale [NRS]; 0 = “no pain,” 10 = “pain as very bad as patient can imagine”) for less than 72 hours. 3. Participants were informed by written consent.
Exclusion criteria
Exclusion criteria: 1. Patients who had a history of lumbar and spinal accident in former 1 year or lumbosacral surgery. 2. Patients who had a history of osteoporosis, immunodeficiency, diabetes mellitus, hypertension, cardiovascular disease, thyroid, endocrine gland disease and asthma. 3. Patients who have a current active peptic-duodenal ulcer, gastro-esophageal reflux disease (GERD). 4. Patients who had a history of epilepsy or recurrent seizures; have current active liver disease (abnormal liver function test or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevated more than 2 times of upper normal limit). 5. Patients who had creatinine clearance (CrCl) less than 50 ml/min or any significant renal disease. 6. Patients who have blood pressure over 140/90 mmHg; known hypersensitivity to Ibuprofen or AVS023 or herbal and pollen grain. 7. Patients who concomitant use of phenytoin, rifampicin, propranolol, theophylline, corticosteroids, other anti-inflammatory, anticoagulant and antiplatelet in a current medication. 8. Pregnancy or lactating. 9. Patients who required treatment with an opioid analgesic. 10. Patients who prior either drugs NSAIDs, AVS023 or any analgesics, anti-inflammatory and muscle relaxants treatment within 1 week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain intensity days 1, 3 and 7 numeric rating scale | — |
Secondary
| Measure | Time frame |
|---|---|
| disability days 1, 3 and 7 Oswestry disability index | — |
Countries
Thailand
Contacts
Public ContactSomruedee Chatsiricharoenkul
Faculty of Medicine Siriraj Hospital Mahidol University
Outcome results
None listed