CTRI/2023/06/053694
Completed
未知
A Prospective, open-label, clinical study to evaluate the efficacy of Sacral Belt in treating mild back pain in male & female volunteers
ITED MEDICARE0 sites15 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITED MEDICARE
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age: 18\-60 years
- •2\.Gender: both male and female subjects
- •3\.Mentally Sound
- •4\.Subjects willing to give a voluntary written informed consent, and agree to come for regular follow up.
- •5\.Subjects with mild back pain.
- •6\.Subjects willing to abide by and comply with the study protocol.
- •7\.Subjects with Lumbar Spondylitis, Spondylolisthesis, Lumbago, Postural Fatigue or Sciatica Pain are included.
- •8\.Individuals willing to use study products for the study duration
Exclusion Criteria
- •1\.Individuals who will not give written consent (wet\-ink/electronic)
- •2\.Pregnancy or breast feeding.
- •3\.Subject having chronic illness or had major surgery in the last year.
- •4\.Presence of other neurological disorders (e.g., multiple sclerosis, Parkinson’s Disease)
- •5\.Subjects with pre\-existing severe systemic disease necessitating long\-term medication.
- •6\.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
- •7\.Participation in the current or previous clinical trial with any approved or
- •8\.investigational products during the past 1 month.
Outcomes
Primary Outcomes
Not specified
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