Efficacy of Ayurved SIRIRAJ SAHATTHARA recipe, in patient with acute low back pain, the open-label randomized controlled trial

Phase 3

Recruiting

• Conditions: Acute low back pain, moderate severity.; Ayurved Siriraj Sahatsatara recipe; Acute low back pain

• Registration Number: TCTR20151118003
• Lead Sponsor: Somruedee Chatsiricharoenkul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-18
• Study Completion: 2017-01-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain reduction and improvement of disabilities 7 days numerical rating scale (NRS) and Oswestry disability index(ODI)

Secondary Outcome Measures

Name	Time	Method
safety 7 days Adverse events and blood test including lCBC, PT, aPTT, AST, ALT, BUN, SCr