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. 2020 Apr 16;2020(4):CD013581. doi: 10.1002/14651858.CD013581

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)