Evaluation of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy

Randomized, Double-Blind Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy

Epinosine B Forte ampoule is an intramuscular injectable supplement containing adenosine triphosphate (ATP), Cocarboxylase (vitamin B1 derivative), vitamin B12, and nicotinamide (vitamin B3). It is used to support nerve function, treat B vitamin deficiencies, enhance cellular energy metabolism, and alleviate symptoms of fatigue, neuropathy, and general weakness. Commonly prescribed for conditions like peripheral neuritis and recovery from nerve-related disorders. Side effects are generally mild and may include local injection site reactions or allergic responses. Clinical evaluation of this investigational product may provide valuable evidence for its efficacy in treating diabetic neuropathy where impaired energy metabolism and micronutrient deficits often coexist. Establishing the efficacy and safety of Epinosine B Forte through a structured clinical trial is therefore essential. Demonstrating clinical benefit would not only inform and optimize current treatment protocols for DPN but also support the potential for broader clinical application which includes routine use in diabetic care, integration into treatment guidelines, and possible extension to other neuropathic conditions where metabolic support may play a therapeutic role

To evaluate the effectiveness of the IMP (Epinosine - B Forte Lyophilized Ampoules) compared to an active control (vitamin B complex only) in improving neuropathic symptoms in patients with symptomatic diabetic polyneuropathy based on a validated neurological symptom scoring system.

Inclusion Criteria:

1. Patients ≥ 18 years of age at time of consent
2. Able to provide informed consent for study participation.
3. Diagnosed with either Type 1 or Type 2 diabetes mellitus, with glycated hemoglobin (HbA1c) ≤ 10%
4. Diagnosed with diabetic polyneuropathy, defined as a Diabetic Neuropathy Symptom (DNS) score ≥ 2, with symptom duration of at least 3 months prior to providing informed consent.
5. Willingness to comply with study procedures and attend scheduled study visits
6. Patients should be on a stable antidiabetic medication regimen for 30 days prior to randomization.

Exclusion Criteria: -

1. Non-diabetic causes of neuropathy, e.g., alcohol abuse, vitamin B12 deficiency, renal failure, or chemotherapy-induced neuropathy other diseases that causes presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.

2. Current or recent (within 30 days from screening visit) use of Neuropathic pain treatments, including:

   2.1 Gabapentinoids (gabapentin, pregabalin),

   2.2Serotonin-norepinephrine reuptake inhibitors (duloxetine, venlafaxine, desvenlafaxine)

   2.3 Tricyclic antidepressants (e.g., amitriptyline) 2.4 Topical capsaicin preparations 2.5 Carbamazepine, 2.6 Oxcarbazepine, 2.7 Lamotrigine 2.8 topiramate 2.9 other agents for neuropathic pain , Sedatives and anxiolytics (Benzodiazepines, Z-drugs (e.g., zolpidem), Barbiturates, Other B-complex or ATP-containing injectable supplements 2.10 Multivitamins or nutritional supplements 2.11 Pentoxifylline or Naftidrofuryl oxalate, Alpha-lipoic acid or other drug classes indicated for treatment of neuropathic pain.

3. Severe comorbidities (e.g., malignancy, liver failure, end-stage renal disease, decompensated heart failure)

4. Pregnancy or breastfeeding

5. Female patients of childbearing potential not using effective contraception (e.g., oral contraceptives, DMPA, IUD, double barrier, sterilization, or confirmed postmenopausal status)

6. Known hypersensitivity to any component of the investigational product

7. Participation in another clinical trial within the past 3 months