Health Condition 1: null- Lower Back Ache
Conditions
Interventions
Intervention1: Lower Back Comfort Capsules: Orally twice a day for 30 days.
Control Intervention1: Placebo capsules: Orally twice a day for 30 days.
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Visual Analogue Scale 2 Owestry Disability Questionnaire. 3 Fingertip-to-Floor Test. 4 Patients and investigators overall assessment. 5 C - reactive protein and Erythrocyte sedimentation rate. 6 Haemogram and Liver Function Test and Renal Function TestTimepoint: 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
| Measure | Time frame |
|---|---|
| To assess the safety of Lower Back Comfort in patients with lower back ache. Safety Outcomes Clinical Safety â?¢ Global Assessment of Tolerability to Therapy [GATT] on a 5-point scale. â?¢ Incidence of the adverse events. â?¢ Laboratory Safety Timepoint: Screening to end of the treatment | — |
Countries
India
Contacts
Public ContactMr Subramanian Jagadeesan
ClinWorld Private Limited
Outcome results
None listed