Effectiveness of individualized homoeopathic medicines in reducing relapse risk in patients with alcohol use disorder -a quasi experimental 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
- ARRS- The Alcohol Relapse Risk Scale will be administered every three months to assess the overall risk of relapse in the study population, with the aim of observing a reduction in the ARRS score, indicating a decreased risk of relapse.
研究概览
简要总结
Study aims to assess the effectiveness of individualized homeopathic medicines in reducing relapse risk among individuals with Alcohol Use Disorder (AUD). Employing a quasi-experimental study, the research will be conducted at the IPD, OPD and camp on National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala. Participants, aged 19 to 65 years and diagnosed with AUD as per DSM-5 criteria, will be selected based on a Severity of Alcohol Dependence Questionnaire (SADQ) score above 16. Exclusion criteria include individuals undergoing psychotherapy, non-pathological drinkers, those in withdrawal, those taking medication for other medical conditions, those with serious life-threatening medical conditions, and pregnant or lactating women. The study utilizes the SADQ and Alcohol Relapse Risk Scale (ARRS) to measure alcohol dependence severity and relapse risk at baseline and every three months for 12 months. A minimum of 38 participants will be enrolled, accounting for a 15% dropout rate. Participants will be screened using a verbal questionnaire based on DSM-5 criteria. Individualized homeopathic medicine will be selected based on standard homeopathic guidelines. The primary objective is to determine if individualized homeopathic medicine reduces relapse risk, while secondary objectives include identifying common relapse causes and determining groups of homeopathic medicines are more effective. The study hypothesizes that there will be a significant difference in relapse risk before and after using individualized homeopathic medicines.
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
- 19.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Diagnosed cases of alcohol use disorder 303.9 as per DSM V criteria.
- •2.Participants in both gender age group between 19-65 years.
- •3.Participants with severity of alcohol dependence questionnaire score above 16.
排除标准
- •1.Participants who currently undergoing any psychotherapies such as cognitive behaviour therapy and dialectical behaviour therapy.
- •2.Non pathological drinker.
- •3.Participants in the withdrawal period.
- •4.Cases with serious life-threatening medical conditions.
- •5.Pregnant and lactating women.
结局指标
主要结局
ARRS- The Alcohol Relapse Risk Scale will be administered every three months to assess the overall risk of relapse in the study population, with the aim of observing a reduction in the ARRS score, indicating a decreased risk of relapse.
时间窗: Every three months from baseline till the conclusion of study.
次要结局
- 1.ARRS-Alcohol relapse risk scale is administered every three months to identify the most common cause of relapse in alcohol use disorder.(2.SADQ – Severity of Alcohol Dependence Questionnaire will be administered three months to assess the overall severity of alcohol dependence in the study population. The aim is to observe a reduction in the SADQ score, indicating a decrease in the severity of alcohol dependence)
