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临床试验/CTRI/2025/06/089335
CTRI/2025/06/089335尚未招募2 期

Effectiveness of Individualised Homoeopathic medicine in LM potency in restricted and repetitive behaviour of autism spectrum disorder-A Quasi experimental study

Dr. Breethni. M1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年4月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
38
试验地点
1
主要终点
Assessment of reduction in restricted and repetitive behaviour after administration of individualised Homoeopathic medicine in LM potency using Repetitive Behaviour Questionnaire-2

研究概览

简要总结

This quasi experimental study evaluates the effectiveness of individualised Homoeopathic medicine in  LM potency in restricted and repetitive behaviour in autism spectrum disorder using repetitive behaviour questionnaire-2(RBQ-2). Secondary objectives include which type of restricted and repetitive behaviour  improved after administration of Homoeopathic medicines in LM potency using Repetitive Behaviour Questionnaire -2 and assessing global improvement of autism using Indian scale for assessment of  autism(ISAA). Patients will be recruited from the Outpatient Department (OPD), Inpatient Department (IPD), and camps of the National Homoeopathy Research Institute in Mental Health  (NHRIMH), Kottayam, following screening based on ICD-11 criteria. Enrollment requires psychiatrist  confirmation, and informed consent will be obtained in English and Malayalam. Baseline assessments include RBQ-2 for restricted and repetitive behaviour and ISAA for global improvement of autism tri-monthly. A detailed case history and mental status examination will be recorded, and individualized homoeopathic remedies will be prescribed based on repertorization via RADAR OPUS software and Homoeopathic Materia Medica. Acute exacerbations will be managed accordingly. The study will track changes in restricted and repetitive behaviour in autism spectrum disorder using LM Potency.Patients missing follow-ups for three consecutive months will be considered dropouts and will receive standard OPD care but will be excluded from further study evaluation. The study aims to find an improvement in reduction in  the Restricted and Repetitive behaviour in children with ASD after the administration of individualized Homeopathic medicine in LM potency.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
3.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 1.Autism spectrum disorder as per ICD-11 criteria.
  • 2.Participants must be children aged between 3-18 years.
  • 3.Children of both sexes.
  • 4.RBQ-2 scoring greater or equal to 20.

排除标准

  • Children suffering from other major psychiatric condition like Rett’s Syndrome, Asperger’ syndrome and stereotyped movement disorder.

结局指标

主要结局

Assessment of reduction in restricted and repetitive behaviour after administration of individualised Homoeopathic medicine in LM potency using Repetitive Behaviour Questionnaire-2

时间窗: Every 3 months from baseline till conclusion of the study

次要结局

  • 1. Determine which type of restricted and repetitive behaviour improved after(administration of Homoeopathic medicines in LM potency using Repetitive Behaviour)

研究者

发起方
Dr. Breethni. M
申办方类型
Other [self]

研究点 (1)

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