Acute low back pain,
Conditions
Interventions
Thai herbal medicine ,NSAIDs
Experimental Drug,Active Comparator Drug
Ayurved Siriraj Sahatsatara recipe (AVS023),Ibruprofen
Sponsors
Somruedee Chatsiricharoenkul
Pinpilai Jutasompakorn
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - nonspecific acute low back pain without leg pain - pain duration less than 72 hours - pain score in numerical rating scale (NRS) are within 4-7
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women or positive pregnancy test women - Blood pressure >140/90 mmHg - History of spine trauma or surgery and osteoporosis. - History of cardiovascular disease, liver or renal impairment, endocrine disorders, neurological disease, gastrointestinal disease and asthma. - AST, ALT> 2 time of UNL or CrCl < 50 mL/min - Immunocompromised host - Allergy to the study drug - Volunteers who used NSAIDs or AVS 023 within 7 days before study participation and Corticosteroids within 4 weeks. - Volunteers who used anti-inflammatory drugs, corticosteroids , anticoagulant , antiplatelet , phenytoin , theophylline , rifampicin , propranolol - History of drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain reduction and improvement of disabilities 7 days numerical rating scale (NRS) and Oswestry disability index(ODI) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety 7 days Adverse events and blood test including lCBC, PT, aPTT, AST, ALT, BUN, SCr | — |
Countries
Thailand
Contacts
Public ContactSomruedee Chatsiricharoenkul
Department of pharmacology
Outcome results
None listed