Effectiveness of individualized homoeopathic medicine for reducing insomnia in generalized anxiety disorder single arm prospective study
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
- Reduction of insomnia by assessing changes in ISI scale score.
研究概览
简要总结
This open-label clinical research aims to assess the effectiveness of individualized homoeopathic treatment in reducing insomnia associated with Generalized Anxiety Disorder (GAD). The primary objective is to reduce insomnia symptoms in GAD patients using the Insomnia Severity Index (ISI). Secondary objectives include evaluating anxiety reduction before and after treatment using the Hamilton Anxiety Rating Scale (HAM-A).Participants diagnosed with insomnia in the context of GAD who visit the Outpatient Department (OPD), Inpatient Department (IPD), or Peripheral OPD at the National Homoeopathic Research Institute in Mental Health (NHRIMH), Kottayam, will be subjected to a structured screening process. Those meeting the DSM-5 diagnostic criteria for insomnia related to GAD will be enrolled after providing written informed consent..A psychiatrist will confirm the diagnosis and record a detailed case history. Routine and specific investigations will be carried out as required to eliminate other potential medical causes. Baseline assessments will include both ISI and HAM-A scores.An individualized homoeopathic totality will be constructed for each participant, and repertorization will be carried out using RADAR software in conjunction with the Synthesis Repertory. Remedies will be selected based on Homoeopathic Materia Medica. Participants will be evaluated periodically for their clinical progress. If there’simprovement, a higher potency of the same medicine may be prescribed. If there is no change, the case will be reassessed, and a new remedy may be selected.Acute symptoms will be treated as needed. Monthly follow-ups will be conducted, and both ISI and HAM-A scores will be reviewed at each visit. Participants missing three consecutive visits will be marked as dropouts and excluded from the study, though they may return later. The goal is to evaluate the effect of individualized homoeopathy in reducing insomnia in patients with GAD.
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Age group between 18-60 of both sexes.
- •Participants fulfilling the DSM-5 criteria for GAD with insomnia.
- •ISI scores greater than or equal 8.
排除标准
- •Participants with insomnia in psychiatric disease other than GAD.
- •Substance induced anxiety disorder.
- •Serious systemic illness (uncontrolled DM, uncontrolled HTN) 4) Pregnant and lactating women.
- •Participants with suicidal ideation.
- •Organic cause of insomnia.
- •Participants those who are taking treatment from other system of medicine for insomnia.
结局指标
主要结局
Reduction of insomnia by assessing changes in ISI scale score.
时间窗: Every from baseline till the conclusion of the | study (12 months)
次要结局
- Reduction of anxiety by assessing changes in HAM-A scale score.(Every from baseline till the conclusion of the)
