A randomized, open label, clinical trial to investigate efficacy and safety of NG02 in preventing the progression of diabetic neuropathy in type 2 diabetes patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To compare the mean change from baseline scores in the Total Symptom Score (TSS) between the two groups over the treatment period.
研究概览
简要总结
Nutrify Genie’s formula contains Alpha Lipoic Acid, Emblica Officinalis std., Beta-Glucogallin, Methylcobalamin, Thiamine, Magnesium, Quaterfoilic, and Zinc. These ingredients offer Anti-inflamatory and Anti-oxidant support and hence help in Nerve support. They have been shown to offer support in improving Diabetic Neuropathy by alleviating oxidative stress, helping to inhibit aldose reductase enzyme. They also help to maintain healthy sugar balance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject should be diagnosed with Type 2 Diabetes Mellitus for a duration of at least 1 year with HbA1c 6%-12% & a score of more than 50% on DN4 questionnaire.
- •Subject should be diagnosed with Mild to Moderate Diabetic Neuropathy for a duration of at least 6 months.
- •Subject is ready to sign the informed consent.
排除标准
- •Subject is not ready to sign the informed consent.
- •ect has major systemic diseases such as malignancy, connective tissue disorders, liver, and renal diseases or any other illness which according to investigator forbids him/her from participating in this clinical trial.
- •Subjects having Neuropathic pain from anything other than diabetes.
- •Subjects who have participated in any clinical study in less than a month before the screening visit.
- •Pregnant or breast-feeding female subjects.
结局指标
主要结局
1. To compare the mean change from baseline scores in the Total Symptom Score (TSS) between the two groups over the treatment period.
时间窗: Day 1( baseline), Month 2, Month 4 & Month 6.
2. To compare the mean change from baseline scores in The Douleur Neuropathique 4 (DN4) questionnaire between the two groups over the treatment period.
时间窗: Day 1( baseline), Month 2, Month 4 & Month 6.
3. To compare the mean change from baseline levels of Malondialdehyde biomarker between the two groups over the treatment period.
时间窗: Day 1( baseline), Month 2, Month 4 & Month 6.
4. To compare the mean change from baseline levels of Nerve Growth Factor between the two groups over the treatment period.
时间窗: Day 1( baseline), Month 2, Month 4 & Month 6.
次要结局
- To compare the improvement of Quality of Life (QoL) from baseline based on Diabetes Quality of Life Questionnaire (DQOL) questionnaire.(Day 1( baseline), Month 2, Month 4 & Month 6.)