To measure serum Vitamin K2-7 levels in patients with peripheral neuropathy due to type 2 diabetes mellitus and/ or vitamin B12 deficiency supplemented with Vitamin K2-7
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to compare the activity and tolerability of Vitamin K2-7 with placebo in patients with peripheral neuropathy and to measure levels of vitamin K2-7 in serum
研究概览
简要总结
An open labelled trial will be conducted to compare the safety and efficacy of Vitamin K2-7 (MK-7) in patients with peripheral neuropathy due to type 2 diabetes mellitus and/ or vitamin B12 deficiency. In this trial, 20 patients will be selected as per the inclusion and exclusion criteria after the approval of Ethics Committee and written informed consent is signed. Each patient will either receive vitamin K2-7 capsule or identical placebo. Blood investigations and clinical examination will be done at every visit. The peripheral neuropathy symptoms were checked at 0 day, 2nd week, 4th week, 8th week and 12th week of visit and will be entered in pain score diary. The gradation of peripheral neuropathy was judged by physician based on visual analogue scale. 10 ml blood was withdrawn on 0 day, 4th week and at 8th week and transferred in a cold chain at -65 ± 10°C to Synergia Life Sciences Pvt. Ltd. for analysis of Vitamin K2-7.
研究设计
- 研究类型
- Interventional
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 and female aged 18 to 65 who are suffering from type 2 diabetes mellitus and/ or vitamin B12 deficiency.
- •Symptomatic diagnosis of neuropathy (>4 on VAS score).
- •Willing to give informed consent.
排除标准
- •Patients who are suffering from any other systemic illness other than type 2 diabetes mellitus or vitamin B12 deficiency.
- •Patients who are on corticosteroids and oral contraceptives
- •Patients with seropositive status.
- •Pregnancy
- •Patients Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
- •Patients who are on coumarin analogues
- •Patients who are on Quinine Hydrochloride
- •History of alcohol.
- •substance abuse or alcoholism, within the previous one year.
结局指标
主要结局
The primary objective of the study is to compare the activity and tolerability of Vitamin K2-7 with placebo in patients with peripheral neuropathy and to measure levels of vitamin K2-7 in serum
时间窗: 0 day, 2nd week, 4th week, 8th week, 12th week
次要结局
- Safety and tolerability; clinical and metabolic variables.(0 day, 2nd week, 4th week, 8th week, 12th week)