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

Not Applicable

Completed

• Conditions: Acute low back pain patient; acute Low Back Pain (LBP); anti- inflammatory, analgesics; AVS023 poly- herbal formula (Ayurved Siriraj Sahatsatara recipe); ibuprofen

• Registration Number: TCTR20141027001
• Lead Sponsor: Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-12-20
• Study Start: 2014-10-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain intensity days 1, 3 and 7 numeric rating scale

Secondary Outcome Measures

Name	Time	Method
disability days 1, 3 and 7 Oswestry disability index