A single-blind randomized controlled trial of AVS023 poly-herbal formula for Acute low back pain: a pilot study

Faculty of Medicine Siriraj Hospital0 sites29 target enrollmentOctober 27, 2014

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2014

End Date

December 20, 2013

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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.

•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.