CTRI/2023/11/060353尚未招募Phase 3 4
A Randomized controlled study comparing Nutraceuticals and Pregabalin in Diabetic Neuropathy
NARNE KRISHNA GEETHA1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2023年12月11日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Visual Analogue Score for Pain
研究概览
简要总结
| This Study is a randomised,open label,parallel group,Multi-arm trial comparing the Nutraceuticals and Pregabalin 75mg in 99 patients with Dibetic Neuropathy that will be conducted in Saveetha medical college in India. The primary outcome measures will be visual analogue score at 12 weeks and Mean daily sleep interference score at 12 weeks.The secondary outcome measures will be Visual Analogue Score at 6 weeks,Patient Global Impression Change scale at 12 weeks and Clinical Global Impression Change Scale at 12 weeks |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged 30 to 75 years
- •Patients with DPN based on their history and complaints were subjected to clinical examination and monofilament testing along with Michigan Neuropathy Screening Instrument (MNSI)
- •Patients with Type 2 DM with glycosylated hemoglobin [HbA1c] ranging between 6.5% and 10.0%
- •Patients with painful DPN ranging from 1 month to 5 years.
- •Patients who provided informed consent.
排除标准
- •Type 2 diabetes mellitus patients, diagnosed in past 1 year were excluded from the study
- •Patients with type 1 diabetes
- •Patients with any history of hypersensitivity reactions to pregabalin or nutraceuticals to be used in the study population.
- •Patients with hyperthyroidism, hypothyroidism, acromegaly, and Cushing’ syndrome
- •Patients with acute complications of Type 2 diabetes mellitus within the period of 6 months
- •Pregnant and lactating women.
结局指标
主要结局
Visual Analogue Score for Pain
时间窗: 12 weeks
次要结局
- Mean Daily Sleep Interference score(12 weeks)
- Patient Global Impression Change scale(12 weeks)
- Clinical Global Impression Change scale(12 weeks)
- Visual Analogue Score for Pain(6 weeks)
研究者
NARNE KRISHNA GEETHA
Saveetha Medical College and Hospital
研究点 (1)
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