The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Degree of regression (Optical Coherence Tomography)
研究概览
简要总结
Nutritional supplements have an augmentative effect on the outcomes of standard treatment of diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).
详细描述
It has been shown that in chronic diseases, oxidative stress results from Nitric acid reacting with oxygen to form toxins that damage both somatic and mitochondrial DNA. The potential for protecting the DNA and promoting repair by using nutritional supplements will be tested by augmenting standard treatments for DME and NAMD with such supplements. The patients will be randomized to treatment group and placebo group and followed up for a year in a double masked fashion. Anatomic and visual outcomes, as well as side effects will be assessed and analyzed. If the results are promising, this pilot study can be used to design alternative (cheaper, better and longer lasting) treatments for DME, NAMD and perhaps other chronic illnesses.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of NAMD
- •Clinical Diagnosis of DME
排除标准
- •Pregnant Women
- •Known allergy to any component used in the treatment combinations
研究组 & 干预措施
P (Placebo)
干预措施: Neutral pills with no medicinal effect (Drug)
S (Supplement)
干预措施: Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals (Dietary Supplement)
SM (Supplement with Minocycline)
干预措施: Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline (Drug)
结局指标
主要结局
Degree of regression (Optical Coherence Tomography)
时间窗: Monthly
Duration of regression (Optical Coherence Tomography)
时间窗: Monthly
Visual change (ETDRS)
时间窗: Monthly
次要结局
- Effect on HbA1C(Monthly)
- Effect on Blood pressure(Monthly)
- Effect on serum uric acid(Monthly)