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

A randomized double-blinded placebo-controlled study to determine the efficacy of Turmeric-Boswellia formulation on subjects with low back soreness and discomfort. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055120

Enrollment

Registered

2023-07-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Turmeric-Boswellia extract: Turmeric-Boswellia extract in sesame oil 500mg soft gel capsules once daily for 15 days Control Intervention1: Placebo: polysorbate-80 and PEG400 in 500mg so

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mean change in the Sum of pain intensity difference at 6 hoursTimepoint: Day 1, 7, 15	—

Secondary

Measure	Time frame
Mean change in Oswestry Disability IndexTimepoint: Day 1, 7, 15;Mean change in Total pain relief at 6 hoursTimepoint: Day 1, 7, 15	—

Countries

India

Contacts

Public ContactSooraj Rajasekharan Kartha

Arjuna Natural Pvt Ltd

drbinu@arjunanatural.com09447818432

Outcome results