Clinical study to evaluate the efficacy and safety of Lower Back Comfort in patients with Lower Back Ache

Active, not recruiting

• Conditions: Lower Back Ache

• Registration Number: CTRI/2018/03/012822
• Lead Sponsor: Sami Labs Limited

Brief Summary

A prospective,multi center, randomized, double blind, placebo controlled study will be conducted in 84 male or female adult human volunteers in the age group of 18 to 70 years with clinical symptoms of low back ache. The individual subject participation will be for 30 days. The efficacy outcomes for the study would be change in Visual analogue scale, Owestry Disability Questionnaire, Fingertip-to-Floor Test, Patients and Investigators overall assessment and biomarkers. Safety outcomes include Global Assessment of Tolerability to  therapy , adverse events, laboratory parameters. Statistical analysis will be performed as listed in the protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 1 Healthy adult volunteers with clinical symptoms of low back ache with no other clinical condition.
• 2 Willing to sign on Informed consent form.
• 3 Patients with low back pain that was not attributable to any identifiable cause, such as disc prolapse, spondylolisthesis, osteomalacia or inflammatory arthritis.

Exclusion Criteria

• 1 Patients with established hypertension, renal, hepatic or cardiac failure, on long-term steroid treatment.
• 2 Patients suffering from autoimmune disorder; spastic condition or genetic disorders.
• 3 Non-adherence to the treatment.
• 4 History of any other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study.
• 5 Low back pain of Class 3 (pain with radiation distally beyond the knee and without neurologic signs) or Class 4 (Pain with radiation to the extremity and with neurologic signs) classified by the Quebec Task Force Classification for Spinal Disorders.
• 6 Patients with specific causes of back pain (i.e. disc prolapse, spondylolisthesis, ischialgia, spinal stenosis), instability of the spine, spinal fractures, tumours, infections and inflammatory disorders, cervical spine syndrome or osteoporosis ,rheumatoid arthritis.
• 7 Known hypersensitivity or intolerance to investigational products.
• 8 Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential.
• 9 Participation in any other clinical study within 30 days of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Visual Analogue Scale	1 VAS(Screening,Day15 and Day30) | 2Questionnaire(Screening,Day15 and Day30) | 3 Fingertip-to-Floor Test(Screening,Day15 and Day30). | 4 Patients and investigators overall assessment(Screening,Day15 and Day30). | 5 CRP and ESR(Day0 & Day30). | 6 Blood Tests(Day0 & Day30).
2 Owestry Disability Questionnaire.	1 VAS(Screening,Day15 and Day30) | 2Questionnaire(Screening,Day15 and Day30) | 3 Fingertip-to-Floor Test(Screening,Day15 and Day30). | 4 Patients and investigators overall assessment(Screening,Day15 and Day30). | 5 CRP and ESR(Day0 & Day30). | 6 Blood Tests(Day0 & Day30).
3 Fingertip-to-Floor Test.	1 VAS(Screening,Day15 and Day30) | 2Questionnaire(Screening,Day15 and Day30) | 3 Fingertip-to-Floor Test(Screening,Day15 and Day30). | 4 Patients and investigators overall assessment(Screening,Day15 and Day30). | 5 CRP and ESR(Day0 & Day30). | 6 Blood Tests(Day0 & Day30).
4 Patients and investigators overall assessment.	1 VAS(Screening,Day15 and Day30) | 2Questionnaire(Screening,Day15 and Day30) | 3 Fingertip-to-Floor Test(Screening,Day15 and Day30). | 4 Patients and investigators overall assessment(Screening,Day15 and Day30). | 5 CRP and ESR(Day0 & Day30). | 6 Blood Tests(Day0 & Day30).
5 C - reactive protein and Erythrocyte sedimentation rate.	1 VAS(Screening,Day15 and Day30) | 2Questionnaire(Screening,Day15 and Day30) | 3 Fingertip-to-Floor Test(Screening,Day15 and Day30). | 4 Patients and investigators overall assessment(Screening,Day15 and Day30). | 5 CRP and ESR(Day0 & Day30). | 6 Blood Tests(Day0 & Day30).
6 Haemogram and Liver Function Test and Renal Function Test	1 VAS(Screening,Day15 and Day30) | 2Questionnaire(Screening,Day15 and Day30) | 3 Fingertip-to-Floor Test(Screening,Day15 and Day30). | 4 Patients and investigators overall assessment(Screening,Day15 and Day30). | 5 CRP and ESR(Day0 & Day30). | 6 Blood Tests(Day0 & Day30).

Secondary Outcome Measures

Name	Time	Method
To assess the safety of Lower Back Comfort in patients with lower back ache.	Safety Outcomes

Trial Locations

Locations (1)

Muthu Hospital; 🇮🇳 Madurai, TAMIL NADU, India

Muthu Hospital

🇮🇳Madurai, TAMIL NADU, India

Dr Mithran

Principal investigator

9894782428

drmithran@gmail.com