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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- To compare the mean change in Diabetic Neuropathy symptoms Score (DNS) from baseline to week 12 between the two study arms
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Epinosine - B Forte Lyophilized
The investigational medicinal product is Epinosine B Forte, a parenteral formulation administered by intramuscular injection
干预措施: adenosine triphosphate (Drug)
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
干预措施: Vitamin B Complex (Drug)
结局指标
主要结局
To compare the mean change in Diabetic Neuropathy symptoms Score (DNS) from baseline to week 12 between the two study arms
时间窗: 12 weeks
A simplified scoring system, the diabetic neuropathy symptom score (DNS) frequently used in clinical trials and medical practice , assessing pain, numbness, tingling and ataxia. The maximum score of DNS is four points, one point or more indicates neurological abnormalities . It was reported to be validated, fast and easy to perform, with a high predictive value when screening for diabetic polyneuropathy . DNS was found to be the most and modified NDS had equal specificity (100%). DNS had a better diagnostic efficacy (70 %) \]sensitive test (65.4%)
次要结局
- Neuropathy- and foot ulcer-specific quality of life (Neuro-QoL)(12 weeks)
- Vibration perception threshold(12weeks)