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

Not Applicable

• Conditions: Health Condition 1: null- Lower Back Ache

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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