Efficacy of Turmeric-boswellia extract in subjects with low back discomfort.

Phase 2

Completed

Brief Summary: The lower back is one of the most affected part in theposture related pain associated with work/lifestyle habits. This is differentfrom the acute pain originating from exercise which arises within 48 hours. Thelower back pain from posture starts mildly and progresses to moderate to severepain and lasts for weeks or till the posture or lifestyle is changed. Turmeric-boswelliaextract has excellent pain reliving properties and this study looks todetermine its pain relieving properties in low back soreness and discomfortcaused by posture. This study includes subjects having pain for at least last2-3 weeks having an NRS score of greater than or equal to 5 at the time ofscreening. This study excludes disc related and lower limb related pain andother systemic illnesses. A mean change in the SPID at 6hrs is the primary endpoint and the study duration is of 15 days.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Mean change in the Sum of pain intensity difference at 6 hours	Day 1, 7, 15

Secondary Outcome Measures

Name	Time	Method
Mean change in Total pain relief at 6 hours	Day 1, 7, 15
Mean change in Oswestry Disability Index	Day 1, 7, 15

Locations (1): Nirmal Hospital
🇮🇳
Jhansi, UTTAR PRADESH, India
Nirmal Hospital
🇮🇳Jhansi, UTTAR PRADESH, India
Dr Ajay Gupta
Principal investigator
9005665599
ajaygupt70@yahoo.com