Evaluation of the efficacy and safety of beta glucan in children with Duchenne Muscular Dystrophy in terms of decreasing inflammatory biomarkers and improving functional mobility
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
Duchenne muscular dystrophy DMD is a rare genetic disease causing muscle degeneration due to lack of dystrophin with inadequate muscle regeneration culminating in muscle dysfunction
The goal of treatment approaches to muscular dystrophies including limb girdle muscular dystrophy, has been to focus on improving the quality of life of patients while maintaining mobility and functional independence for as long as possible apart from effectively managing the comorbidities. The complexity of the disease makes the challenges enormous.
The beneficial effects of a 1 3 1 6 beta-glucan from the N 163 strain of the black yeast Aureobasidium pullulans BGCAN in decreasing inflammatory biomarkers such as interleukin 6 and tumor growth factor and interleukin 13 and increased dystrophin levels as well as improved muscle strength in patients with DMD in a clinical study conducted in 28 patients for a 45-day period and then the muscle improvement in a study of 6 months.
The N 163 strain of Aureobasidium pullulans produced beta 1 3 1 6 glucan reported to be safe with anti inflammatory and anti fibrotic efficacy So we wanted to detect the reduction in inflammatory markers and functional mobility score in patients with DMD after enrolling in the trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 15.00 Year(s)(—)
- 性别
- All
入选标准
- •Subject willing to and able to comply with protocol.
排除标准
- •Patients with a previous (within past 1 month) or concomitant participation in any other therapeutic trial 2) Subjects and legally authorized representative for vulnerable subjects who has not given informed consent 3) Subjects with history of other muscular atrophy disorder 4) Subjects with known or suspected malignancy, any other chronic disease or clinically relevant limitation of renal, liver or heart function according to the discretion of the investigator.
研究者
Dr Suvarna Magar
MGM Medical College
