Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention1: Vitrace Pal: Palmitoylethanolamide (PEA), magnesium,
nucleotides (cytidine and uridine monophosphates), B-complex vitamins, L methylfolate, and
vitamin B12. once daily after food, morni
Sponsors
East west Pharma India Pvt.Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with BMI 18.5 and 34.9 kg/m2. 2. Participants with clinical symptoms suggestive of neuropathy such as pain, tingling, numbness, burning sensation or sensory disturbances. 3. Participants who are able to understand and sign written informed consent and to comply with protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Participants with uncontrolled clinically significant serious conditions like severe anemia, severe cardiovascular, hepatic, renal, urological, autoimmune diseases, malignancy/bleeding disorder. 2. Participants with psychiatric disorder (e.g. major depressive disorder, bipolar disorder, anxiety disorder, schizophrenia, drug and/or addiction abuse or dependence). 3. History of smoking and alcohol consumption. 4. Participants with ongoing infections (e.g., tuberculosis, hepatitis B or C, serious bacterial infections). 5. Participants with severe, progressive, or unstable neurological disorders affecting the central or peripheral nervous system. 6. Participants who have received any investigational product or any formulation containing ingredients similar to the investigational product within 3 months prior to screening. 7. Participants with uncontrolled type 2 diabetes mellitus (HbA1c More than 10 percentage). 8. Women who are pregnant, breastfeeding, or planning pregnancy during the study. 9. Participants with known history or present condition of allergic response to any of the ingredients in the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in neuropathic symptoms from baseline as assessed by the study-defined neuropathy assessment scale. 2. Comparison of change in efficacy parameters between the Vitrace-Pal group and the active control group.Timepoint: 1. Reduction in neuropathic symptoms as assessed by the study-defined neuropathy assessment scale from baseline (Week 1) to End of study (Week 12). 2. Comparison of change in efficacy parameters between the Vitrace-Pal group and the active control group from baseline (Week 1) to End of study (Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Fatigue Assessment Scale (FAS) score from baseline. Change in Short Form-12 (SF-12) Health Survey score from baseline. Assessment of treatment compliance. Incidence, nature, and severity of adverse events.Timepoint: Throughout the study period (Day 0 to Day 90). | — |
Countries
India
Contacts
Public ContactDr B Mothishwaran
Interdisciplinary Institute of Indian System of Medicine
Outcome results
None listed