Health Condition 1: M543- Sciatica
Conditions
Interventions
Intervention1: WELLPEA : 1 sachet to be mixed in one glass of water till fully dissolved and has to be taken orally immediately after food once a day in the morning.
Control Intervention1: Not Applica
Sponsors
GIELLEPI S.p.A
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male or female subjects (age 18-65 yrs). 2.Subjects diagnosed with chronic (lasting for atleast 3 months) lower back pain due to sciatica. 3.Radiating pain into one leg below the knee. 4.Pain score between 4 - 6 on Numerical rating score (NRS). 5.DN4 score more than 4. 6.Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 7.Patient should be able to give written informed consent prior to participating in the study.
Exclusion criteria
Exclusion criteria: 1.Any serious spinal pathology (e.g. cauda equina syndrome, spinal fracture). 2.Spinal surgery or interventional procedures scheduled for sciatica during the 4 week treatment period. 3.On a medication for neuropathic pain, a tricyclic antidepressant or a sedative and unable to cease the medication. 4.Subjects taking nutraceuticals containing PEA, alpha lipoic acids, botanical extracts and other functional ingredients able to reduce LBP and/or intefearing with the Endocannabinoid system. 5.Steroidal anti-inflammatory drugs, NSAIDs during the month prior to screening. 6.Any fractures as well as muscle sprain. 7.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases, infections). 8. High alcohol intake (more than 2 drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana etc). 9.Subjects with known sensitivity to any components of the investigational product. 10.Pregnant or breastfeeding women, and males or females planning conception during the 4 week treatment period. 11.Participation in concomitant interventional clinical study or during the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of pain (NRS less than 4) in atleast 50% of subjects. Change in pain using NRS. Change in pain using NPS. Change in Daily life disability by Oswestry Disability Index (ODI). Change in DN4.Timepoint: Screening, Week 1,2,3 & 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical Examination 2.Vital Signs: Pulse rate, blood pressure & body temperature 3.Lab assessment 4.Adverse Event AssessmentsTimepoint: Screening, Week 1,2,3 & 4. | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd
Outcome results
None listed