None listed
Conditions
Interventions
Intervention1: ALSODY (Alpha Lipoic Acid and Superoxide Dismutase): Alpha-lipoic acid (ALA) is a potent antioxidant that has shown promise in managing neuropathic pain conditions. It acts by scavengin
Sponsors
Fourrts (India) Laboratories Pvt.Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients aged 18-75 years Participants with a diagnosis of chronic low back pain, persisting for 3 months and who are receiving Alsody as part of their routine care. Baseline pain intensity score great than or equal to 4 on the 0 to 10 NRS Patients who are ready to give written informed consent and comply with the protocol requirements Patients who are willing to take medications as directed and come for the follow up
Exclusion criteria
Exclusion criteria: Patients with known hypersensitivity reaction to any of the drugs in the study. Radicular pain or neurological deficits History of spinal surgery within the past 6 monthsCurrent or planned pregnancy or breastfeeding 5. Severe comorbid conditions that could interfere with study participation in the opinion of the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of changes in pain intensity measured using a 0-10 Numeric Rating Scale (NRS) from screening to end of the study (day 60).Timepoint: From Screening till the end of every visit From Screening till the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in functional ability measured by the Oswestry Disability Index (ODI) at baseline and day 60. 2. Assessment of patients’ satisfaction to their treatment by using 5-point Likert scale at day 60 (end of the study). Timepoint: From Screening till the end of every visit From Screening till the end of study | — |
Countries
India
Contacts
Public ContactDr Sudhir
Sri Ramachandra Institute of Higher Education & Research
Outcome results
None listed