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

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20141027001
• Date of registration: 27/10/2014
• Prospective Registration: No
• Primary sponsor: Faculty of Medicine Siriraj Hospital
• Public title: A single-blind randomized controlled trial of AVS023 poly-herbal formula for Acute low back pain: a pilot study
• Scientific title: A single-blind randomized controlled trial of AVS023 poly-herbal formula for Acute low back pain: a pilot study
• Date of first enrolment: 01/03/2013
• Target sample size: 29
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20141027001
• Study type: Interventional
• Study design: Randomized
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Somruedee Chatsiricharoenkul
• Affiliation: Faculty of Medicine Siriraj Hospital Mahidol University

• Name: Somruedee Chatsiricharoenkul
• Affiliation: Faculty of Medicine Siriraj Hospital Mahidol University

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

acute Low Back Pain (LBP)
anti-inflammatory, analgesics
AVS023 poly-herbal formula (Ayurved Siriraj Sahatsatara recipe)
ibuprofen

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

Intervention(s)

Ayurved Siriraj Sahatsatara recipe (AVS023) is a poly-herbal formula used in Thai traditional medicine,Ibuprofen is an non-steroidal anti-inflammatory drugs (NSAIDs)

AVS023,Ibuprofen

Experimental Drug,Active Comparator Drug

Primary Outcome(s)

pain intensity days 1, 3 and 7 numeric rating scale

Secondary Outcome(s)

disability days 1, 3 and 7 Oswestry disability index

Source(s) of Monetary Support

Siriraj Graduate Scholarships and the Siriraj Research Development Fund

Ethics review

Status: Submitted, approved
Approval date:
Contact:

[e-mail]

Siriraj Institution Review Board

[phone] Ext.

[e-mail]

Results

• Date Completed: 20/12/2013