Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
None listed
Sponsors
Saisa Medi LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged between 30 and 75 years. 2. Participants with elevated fasting blood sugar levels greater than 126 mg/dl and random blood sugar levels greater than 140 mg/dl. 3. Participants diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the diagnostic criteria set by the World Health Organization (WHO). 4. HbA1c levels greater than 7%. 5. Diagnosis of peripheral neuropathy confirmed using the Douleur Neuropathique 4 (DN4) questionnaire. 6. Pain intensity score greater than or equal to 4 on the Numeric Pain Rating Scale (NPRS) in the past week. 7. Participants experiencing daily neuropathic pain for at least 6 months. 8. Use of insulin therapy or oral hypoglycemic agents, other than metformin. 9. Participants must have the ability and willingness to provide written informed consent. 10. Participants must be willing to comply with the study protocol, which includes regular sublingual administration, fasting requirements, application of investigational products, and attending all scheduled study visits.
Exclusion criteria
Exclusion criteria: 1.History of severe comorbid conditions, including: Cardiovascular diseases. Hepatic dysfunction. Renal dysfunction. 2. Known hypersensitivity or allergic reactions to any ingredients in the investigational products. 3. Pregnant or lactating women. 4. Participation in any other clinical trial within 30 days prior to screening. 5. History of neurological disorders unrelated to diabetic peripheral neuropathy, such as multiple sclerosis or stroke. 6. Presence of mononeuropathy or other causes of neuropathy, including vitamin B12 deficiency, hypothyroidism, or alcohol-related neuropathy. 7. Current or recent treatment with systemic corticosteroids, anticonvulsants, or antidepressants specifically for neuropathic pain management. 8. History of severe psychiatric illnesses, including major depression, schizophrenia, or any other serious mental health conditions. 9. Any other condition, at the discretion of the investigator, that may interfere with the conduct or interpretation of the study results, including but not limited to cognitive impairments or medical conditions that require ongoing management during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Glycemic Control 1. Reduction in HbA1c levels from baseline to Day 90. 2. Improvement in fasting blood sugar (FBS) and random blood sugar (RBS) levels from baseline to Day 90. Neuropathy and Pain Management 1. Reduction in pain intensity as measured by the Numeric Pain Rating Scale (NPRS) from baseline to Day 90. 2. Improvement in neuropathic symptoms as assessed by the Neuropathic Pain Symptom Inventory (NPSI) from baseline to Day 90.Timepoint: Day 0, Day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of Life Improvement 2.Improvement in Sleep Quality 3. Safety and Tolerability 4. Compliance with TreatmentTimepoint: Day 0, Day 30, Day 60 and Day 90 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed