Health Condition 1: M792- Neuralgia and neuritis, unspecified
Conditions
Interventions
None listed
Sponsors
Accelia Sante Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 65 years at the time of enrollment. 2. Clinically diagnosed with neuropathic pain for at least 3 months. 3. Baseline average pain intensity score of 4 or more on the 11-point Numeric Rating Scale (NRS). 4. Willing to avoid starting any new topical or systemic treatment for neuropathic pain during the study period. 5. Willing and able to provide written informed consent. 6. Willing to comply with all study procedures and protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Participation in another clinical trial 2. Pain mainly caused by acute injury, inflammatory conditions, or cancer rather than neuropathic pain 3. Diabetic neuropathy or uncontrolled diabetes mellitus 4. Severe uncontrolled systemic diseases such as significant liver or kidney impairment that may affect study participation or results 5. Significant psychiatric disorders that may interfere with pain assessment or study compliance 6. Known allergy or hypersensitivity to any component of the investigational product 7. Pregnant or breastfeeding women 8. Substance abuse or alcohol dependence within 1 year 9. Any condition deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in pain intensity measured by the 11-point Numeric Rating Scale (NRS) from Baseline to End of Treatment (Day 90). 2. Assessment of reduction in average neuropathic pain intensity using the NRS score ranging from 0 (no pain) to 10 (worst possible pain). 3. Evaluation of clinically meaningful improvement in pain severity during the treatment period. Timepoint: Visit 1 (Day 0) Visit 2 (Day 30 2 days) Visit 3 (Day 60 2 days) Visit 4 (Day 90 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Neuropathic Pain Severity: a) Change in Douleur Neuropathique 4 (DN4) questionnaire total score from Baseline to Day 90. b) Proportion of participants with DN4 score less than 4 at Day 90, indicating reduction of neuropathic pain features. Timepoint: Visit 1 (Day 0) Visit 2 (Day 30 2 days) Visit 3 (Day 60 2 days) Visit 4 (Day 90 2 days);2. Change in Patient-Reported Global Improvement: a) Patient Global Impression of Change (PGIC) score assessed at Day 30 ( 2 days), Day 60 ( 2 days) and Day 90 ( 2 days; End of Treatment), reflecting overall patient-perceived change in neuropathic pain compared to Baseline (Day 0). b) Distribution of PGIC responses (7-point scale) at each post-baseline visit. c) Proportion of participants with clinically meaningful improvement at each visit, defined as PGIC score of 1 (Very much improved) or 2 (Much improved). d) Change in the proportion of participants achieving clinically meaningful improvement over time (Day 30, Day 60, and Day 90). Timepoint: Visit 1 (Day 0) Visit 2 (Day 30 2 days) Visit 3 (Day 60 2 days) Visit 4 (Day 90 2 days);3. Change in Inflammatory Biomarkers (Subset of 15 Participants): a) Change in serum levels of Interleukin-6 (IL-6), Interleukin-1 beta (IL-1 beta), Tumor Necrosis Factor-alpha (TNF-alpha) and C-Reactive Protein (CRP) from Baseline to Day 90. b) Evaluates biological changes associated with inflammation and their potential relationship with pain reduction. Timepoint: Visit 1 (Day 0) Visit 2 (Day 30 2 days) Visit 3 (Day 60 2 days) Visit 4 (Day 90 2 days);4. Safety and Tolerability a) Incidence, type, severity, and causality of Adverse Events (AEs) throughout the study. b) Any serious adverse events (SAEs) reported during the study period. c) Incidence and severity of any treatment-emergent clinical or laboratory abnormalities. d) Change in laboratory parameters (CBC, HbA1c), vital signs, and physical examination findings from Baseline. e) Investigator | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Accelia Sante Pvt. Ltd
Outcome results
None listed