Efficacy of Turmeric-boswellia extract in subjects with low back discomfort.
- Registration Number
- CTRI/2023/07/055120
- Lead Sponsor
- Arjuna Natural Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
Male or female 18 to 70 years of age
Posture related low back pain
NRS score greater than 5 pain at the time of screening.
BMI 18 to 29kg/m2
History of herniated or ruptured disc, Sciatica, inflammatory arthropathy, severe rheumatoid arthritis, severe osteoarthritis, fibromyalgia, gout, kidney infection, failure or stones, scoliosis or spondylolisthesis, Past injuries like fractures, tears or trauma to the spine, and tumour or spinal cancer.
Acute 48-hour pain due to some exercise.
Knee surgery within the past 6 months, expectations of surgery in the next 4 months, Intra-articular corticosteroid injections within the preceding 3 months.
No neurological symptoms like numbness or weakness in the legs. Muscle pain does not involve compression or irritation of the spinal nerves.
BMI greater or eqaul to 30
High alcohol intake greater than 2 standard drinks per day
Smoking status not more than 1 pack per day
Concomitant medications antibiotics, NSAIDS, steroids, OTC pills and ointments for pain 1 week before screening. Patients taking any joint pain supplements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in the Sum of pain intensity difference at 6 hoursTimepoint: Day 1, 7, 15
- Secondary Outcome Measures
Name Time Method Mean change in Oswestry Disability IndexTimepoint: Day 1, 7, 15;Mean change in Total pain relief at 6 hoursTimepoint: Day 1, 7, 15