Comparative Efficacy of Individualized Homoeopathic Medicines, Ruta Graveolans 30C and Physostigma 6C in Progressive Myopia in children: A single blind, randomized comparative trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Annual myopic progression rate
研究概览
简要总结
The study titled ’Comparative Efficacy of Individualized Homoeopathic Medicines, Ruta Graveolans 30C and Physostigma 6C in progressive Myopia in children is a single blind, randomized, comparative trial with the primary objective to assess changes in the progression rate of vision acuity in children with myopia and secondary objective is to assess changes in the progression rate of vision acuity in children with myopia. The duration of the study will be 2 years wherein duration of participation and intervention in the study shall be one year for individual participants. Participants of age 6- <10 years, both sexes with Refractive error of -1.00 D to -5.0 D without glasses and Minimum spherical equivalent (SE) -(minus)1D. (SE=sphere+1/2 cylinder) will be included in the study. Myopia related to retinal dystrophies or collagen syndromes, and developmental disorders, children suffering from illness like autism, intellectual diasbilities, ADHD, Congenital cataract, retinal detachment or myopic macular degeneration, children suffering from malnutrition which will be defined as standard deviation of < -1 SD of basic metabolic index according to Rastriye bal swasthya karyakaram chart for BMI chart for age 6 to 18 years (Z score), participants unable to come for regular fortnightly follow up and legally authorized reperesentative is unable to give consent for the homoeopathic treatment will be excluded. The primary outcome measure includes annual myopic progression rate to be assessed at baseline and every 3 months for 1 year by snellen chart. the secondary outcome measures include axial length, curvature changes and annual axial length progression rate to be assessed at baseline and 12 months after initiation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Refractive error of between minus 1 diopters to minus 5 diopters without glasses Minimum spherical equivalent (SE) to be minus 1 D (SE= sphere+1/2 cylinder).
排除标准
- •Myopia related to retinal dystrophies or collagen syndromes, and developmental disorders.
- •Children suffering from illness like Autism, Intellectual Disability, Attention Deficit Hyperactive Disorder, Congenital Cataract, Retinal detachment or Myopic macular degeneration.
- •Children suffering from Malnutrition which will be defined as Standard deviation of less than 1 of basic metabolic index according to Z score Rashtriya Bal Swasthya Karyakaram chart for BMI chart for age 6 to 18 years (Z sccore).
- •Participants unable to come for regular fortnightly follow up Legally authorized representative (LAR) are unable to give consent for the homoeopathic treatment.
结局指标
主要结局
Annual myopic progression rate
时间窗: Baseline, end of 3 months, 6 months, 9 months and 12 months
次要结局
- Annual axial length progression rate(Baseline and end of 12 months)
- Axial length (AL)(Baseline and end of 12 months)
- Curvature changes(Baseline and end of 12 months)
研究者
Dr Divya Taneja
Central Council for Research in Homoeopathy
