CTRI/2022/03/041503已完成不适用
An Open Label, Single Arm, Study to Assess the Efficacy and Safety of Menaquinone-7 (Vitamin K2-7) in Subjects with Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Summed change in sensory NCV from baseline of the bilateral sural , proximal and distal median sensory nerves
研究概览
简要总结
This Study is an Open Label, Single Arm, Study to Assess the Efficacy and Safety of Menaquinone-7 (Vitamin K2-7) in Subjects with Diabetic Peripheral Neuropathy
The objectives of the study are to evaluate the Efficacy and Safety of Menaquinone-7 (Vitamin K2-7) in patients with Diabetic Peripheral Neuropathy.
Primary Endpoints:
- Summed change in sensory NCV from baseline of the bilateral sural , proximal and distal median sensory nerves
Secondary Endpoints:
- Change in VAS scale as assessed from the baseline to end of the study.
- Change from baseline in the individual NCVs.
- Change from baseline in the individual nerve amplitudes.
- Change from baseline in the individual nerve latency.
- Change from baseline in the serum Osteocalcin (cOC and ucOC) levels.
- Change from baseline in the serum Vitamin K2-7 levels.
Safety End Point:
- The assessment of safety of Investigational Product will be based on the frequency of Adverse Events
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female subjects with age 18 to 65 years of age( both inclusive)
- •Subjects with known case of Type 2 Diabetes Mellitus (on regular and stable medication from last 3 months).
- •Subjects presenting with symptoms of impaired peripheral neuropathy defined by bilateral decreased or absent reflexes at the ankles, or bilateral decreased vibration, pinprick, fine touch or temperature perception in the distal lower extremities; and confirmed by nerve conduction velocity (NCV) studies.
- •Subjects with symptomatic diagnosis of peripheral neuropathy with pain severity score of (>4 on VAS score).
- •Subjects who are willing to sign informed consent for participation in.
排除标准
- •Subjects with history of diabetic foot ulcers (Wagner Grade ≥1) or lower extremity amputation, diabetic amyotrophy, or non-diabetic cause of lower limb neuropathy
- •Any condition that may lead to confusion of the diagnostic of painful DPN, in particular amputations other than fingers/toes-, not diabetic neurological disorder and skin conditions that may affect sensation at the painful limbs.
- •Subjects who are unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study
- •Subjects who are on corticosteroids and oral contraceptives within 2 weeks of screening visit
- •Subjects who are on coumarin analogues or Quinine Hydrochloride within 2 weeks of screening visit
- •Subjects with Hepatic impairment defined as Serum Bilirubin, SGOT or SGPT > 2 x upper limit of normal (ULN)
- •Subjects with impaired renal function defined as either serum creatinine level > 2 mg/dL or requiring hemodialysis
- •Subjects with uncontrolled hypertension at screening (sitting systolic >160 mmHg and/or sitting diastolic >90 mmHg
- •Subjects with Congestive heart failure Class III or IV of the New York Heart Association (NYHA)
- •Subjects with serious or unstable coronary heart disease, hepatic, kidney, respiratory, hematological alterations, problems with peripheral vascular disease, or other medical or psychiatric conditions that can put in risk the participation of the subject in the study.
- •Subjects with Glycosylated haemoglobin (HbA1c) greater than (≥) 10 percent at screening
- •Subjects with arthritis, sciatic, fibromyalgia, restless leg syndrome, non-neuropathic muscle-skeletal pain or back chronic pain
- •Subjects who are Pregnant or Breast feeding.
- •Subjects with history of alcohol.
- •substance abuse or alcoholism, within the previous one year
- •Subjects Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
结局指标
主要结局
Summed change in sensory NCV from baseline of the bilateral sural , proximal and distal median sensory nerves
时间窗: 8 Weeks
次要结局
- Change from baseline in the individual nerve latency.(8 Weeks)
- Change from baseline in the serum Osteocalcin (cOC and ucOC) levels.(8 weeks)
- Change in VAS scale as assessed from the baseline to end of the study.(8 Weeks)
- Change from baseline in the individual NCVs.(8 Weeks)
- Change from baseline in the individual nerve amplitudes.(8 Weeks)
- The assessment of safety of Investigational Product will be based on the frequency of Adverse Events.(8 Weeks)
- Change from baseline in the serum Vitamin K2-7 levels.(8 weeks)
研究者
研究点 (1)
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