Evaluation of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adenosine triphosphate, Vitamin B Complex.
- Who it may be relevant to
- Registry conditions: Neuropathic Pain. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed description
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.
Interventions
- Drug adenosine triphosphate
Each lyophilized ampoule contains: Adenosine Triphosphate (ATP) - 10 mg Cocarboxylase (Vitamin B1 derivative) - 50 mg Nicotinamide (Vitamin B3) - 20 mg Vitamin B12 (Cyanocobalamin) - 500 mcg - Drug Vitamin B Complex
Each ampoule contains: Cocarboxylase 50 mg Vitamin B12 500 mcg Nicotinamide 20 mg
Primary outcome measures
- To compare the mean change in Diabetic Neuropathy symptoms Score (DNS) from baseline to week 12 between the two study arms [Time frame: 12 weeks]
Secondary outcome measures (2)
- Neuropathy- and foot ulcer-specific quality of life (Neuro-QoL) [Time frame: 12 weeks]
- Vibration perception threshold [Time frame: 12weeks]
Eligibility criteria
Inclusion criteria
- Patients ≥ 18 years of age at time of consent
- Able to provide informed consent for study participation.
- Diagnosed with either Type 1 or Type 2 diabetes mellitus, with glycated hemoglobin (HbA1c) ≤ 10%
- 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.
- Willingness to comply with study procedures and attend scheduled study visits
- Patients should be on a stable antidiabetic medication regimen for 30 days prior to randomization.
Exclusion Criteria: -
- 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.
- 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.
- Severe comorbidities (e.g., malignancy, liver failure, end-stage renal disease, decompensated heart failure)
- Pregnancy or breastfeeding
- Female patients of childbearing potential not using effective contraception (e.g., oral contraceptives, DMPA, IUD, double barrier, sterilization, or confirmed postmenopausal status)
- Known hypersensitivity to any component of the investigational product
- Participation in another clinical trial within the past 3 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07296354 · ABOVE · ABOVE-2501