CTRI/2024/12/077817尚未招募不适用
To assess the effectiveness of Individualized Homoeopathic Medicine using Complete Repertory with standard therapies in the management of global developmental delay in children : A Randomized Single-Blind Double-Arm Placebo-Controlled Clinical Study
Principal Bakson Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- At the end of this study, it is expected that Complete repertory will be of utility in selection of Homoeopathic similimum in the management of cases of GDD in children.
研究概览
简要总结
This Study is to assess the role of Homoeopathic Medicines in the treatment of Global Developmental Delay
Sample Size 70
Randomized, Sigle Blind, Double Arm, Placebo Controlled Clinical Study
15 months study
Scale to be used at baseline, 3rd month and 6th month
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
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children under the age of 5 years of both sexes diagnosed with Global Developmental Delay (GDD), regardless of race, caste, religion, or socioeconomic status.
- •Children who are currently receiving standard therapies, including: Occupational Therapy Language Therapy Speech Therapy Physiotherapy Children diagnosed with Global development delay along with other co-morbidities like: Autism Spectrum Disorder (ASD) Cerebral Palsy (CP) Attention-Deficit/Hyperactivity Disorder (ADHD) Down Syndrome Turner Syndrome Klinefelter Syndrome.
排除标准
- •Children with severe chronic physical disorders that might interfere with the assessment of GDD.
- •Children who are severely ill and require hospitalization.
- •Children with profound global developmental delay (SQ Below 20).
- •Children with uncontrolled or unstable psychiatric conditions and severe neurodevelopmental disorders.
- •Children with severe or profound sensory impairments (eg total blindness or deafness).
- •Children who are currently involved in other clinical trials or interventions that might conflict with or bias the outcomes of this study.
- •Children whose parents or guardians are unable to provide written informed consent or who do not comply with study requirements.
结局指标
主要结局
At the end of this study, it is expected that Complete repertory will be of utility in selection of Homoeopathic similimum in the management of cases of GDD in children.
时间窗: 15 Months study | 6 months Enrolment period | 6 months Follow-up | 3 months Report writing and Data Analysis
次要结局
未报告次要终点
研究者
Dr Lalit Kumar Chauhan
Bakson Homoeopathic Medical College and Hospital
研究点 (1)
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