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

Sponsor
Egyptian International Pharmaceutical Industries Co
Study ID
NCT07296354
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • adenosine triphosphate — DRUG
    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
  • Vitamin B Complex — DRUG
    Each ampoule contains: Cocarboxylase 50 mg Vitamin B12 500 mcg Nicotinamide 20 mg

Study Details

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

Key Dates

First listed
Dec 22, 2025
Start date
Jan 10, 2026
Status verified
Dec 2025
Primary completion
Feb 10, 2028
Completion
Jan 10, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Epinosine - B Forte Lyophilized
    The investigational medicinal product is Epinosine B Forte, a parenteral formulation administered by intramuscular injection
  • Placebo Comparator: vitamin B complex only
    The active control is a vitamin B-complex injectable formulation that does not contain ATP; manufactured by the sponsor specifically for clinical trial use only

Primary Outcome Measure

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 ]

Central Contacts

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