TCTR20141027001.
Methods | RCT, open‐label; pilot study (safety/efficacy study); follow‐up time: 7 days |
Participants |
Population and setting: 29 participants with acute low back pain in Thailand Inclusion criteria: age 18 to 65 years, nonspecific acute low back pain (≥ 4/10 NRS) for under 72 hours Exclusion criteria: history of lumbar and spinal accidents in the previous year or lumbosacral surgery, history of osteoporosis, immunodeficiency, diabetes mellitus, hypertension, cardiovascular disease, thyroid/endocrine gland disease and asthma, active ulcer, epilepsy, seizures, liver disease, renal disease, hypertension, known allergies for ibuprofen or herbal/pollen grain, pregnancy or lactation, certain co‐medication, or recent treatment with test medication |
Interventions |
NSAID (i): NSAIDs; oral Ibuprofen 400 mg, 3 times daily (7 days) Reference treatment (ii): Thai herbal medicine; oral Ayurved Siriraj Sahatsatara recipe (AVS023) 1350 mg, 3 times daily (7 days) |
Outcomes | Pain intensity (NRS); disability (ODI); safety (adverse events and blood test) |
Notes | 1. Study title. A single‐blind randomised controlled trial of AVS023 poly‐herbal formula for acute low back pain: a pilot study 2. We contacted the corresponding author to ask for clarification (21 September 2019) |