A Study on the Effectiveness of Individualized Homoeopathic Intervention in ADHD using Biomarkers & Standard Questionnaires: A single blind randomized Placebo controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To determine the overall improvement of the ADHD symptoms and general improvement of the patient using Homoeopathic follow up analysis/sheet after administration of the remedy.
研究概览
简要总结
Title
A study on the Effectiveness of Individualized Homoeopathic Intervention in ADHD using Biomarkers & Standard Questionnaires: A Single blind randomized Placebo controlled trial.
Aim
To know the effectiveness of Individualized Homoeopathic Medicines in the management of ADHD patients.
Methodology
Single blind Randomized Placebo Control Trial
Study Duration
Enrolment - 09 months
Follow up - 12 months
Data Compilation & Publication - 03 months.
Objectives
-
To understand the therapeutic impact of Homoeopathic Individualized drug potencies in ADHD.
-
To know the relationship between the abnormal readings of biomarkers in cases diagnosed with ADHD and to propose a hypothesis to relate the ADHD symptoms and biomarkers in relation to homoeopathic drug effects.
Study Centre
National Homoeopathy Research Institute in Mental Health, kottayam
Sample Size
64 Participants.
(32 homoeopathic intervention and 32 Placebo group)
Assessment Tools used
- Conners abbreviated rating scale
2.ADHD Rating scale IV - Home and Teacher Version
3.Weiss Functional Impairment Scale - Self and Parent version
4.Biomarkers - S. Lactate, S. Ammonia,
S. Ferritin, S. Zinc
Outcome
To understand the effectiveness of Individualized homoeopathic medicines in treating ADHD patients through difference in the scores of assessment tools, Homoeopathic follow up analysis/sheet and general improvement of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •The cases between age group of 03 – 14 years of age
- •Both sexes
- •Confirmed to DSM- 5 diagnostic criteria for ADHD.
排除标准
- •Cases with chronic medical conditions,
- •Congenital anomalies/Disorders,
- •Seizures or any other serious physical illness,
- •Other Co morbid psychiatric conditions,
- •Patients not willing to give consent,
- •Patients under psychoactive drugs in the past two weeks.
结局指标
主要结局
To determine the overall improvement of the ADHD symptoms and general improvement of the patient using Homoeopathic follow up analysis/sheet after administration of the remedy.
时间窗: 1 year
次要结局
- Mean Difference in ADHD Rating Scale IV and Weiss functional impairment scale(01 year)