Effectiveness of individualized homoeopathic medicines in reducing the difficulties in emotion-regulation in alcohol dependent individuals
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- DERS (Difficulties in Emotion Regulation Scale) will be administered in baseline and monthly for 12 months to evaluate the effectiveness of individualized homoeopathic medicines in reducing difficulties in emotion regulation in alcohol-dependent individuals with AUDIT score above 13 in women and above 15 in men and having DERS-SF(DERS-Short Form) total score of 39 or more. The aim is to observe a reduction in the DERS score, indicating an improvement in emotion regulation after giving individualized homoeopathic medicines.
研究概览
简要总结
This study is an open label single arm clinical interventional study to determine the effectiveness of individualized homoeopathic medicines in reducing the difficulties in emotion-regulation in alcohol dependent individuals, that will be conducted in Psychiatry OPD and IPD of National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala, India. The primary outcome measure will be reduction in Difficulties in Emotion Regulation scale scores, which is to be done at baseline and every monthly for 12 months. The secondary outcomes will be reduction in severity of craving assessed using the Penn Alcohol Craving Scale every monthly and reduction in severity of dependence assessed using the Severity of Alcohol Dependence Questionnaire scale once in three months. This study tries to explore the effectiveness of individualized homoeopathic medicines in reducing the difficulties in emotion-regulation in alcohol dependence individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in the age group between 18 to 70 years.
- •2.Cases diagnosed as Alcohol Dependence F10.2 criteria as per ICD-
- •3.Patients with AUDIT score of 13 or more in women, and 15 or more in men.
- •4.Patients with DERS-SF score of 39 or above.
排除标准
- •1.Patients with acute alcohol withdrawal and intoxication symptoms.
- •2.Cases with dependence on other substances.
- •3.Patients who are currently on psychotropic medications.
- •4.Patients who currently undergoing any psychotherapies such as CBT and DBT.
- •5.Cases with serious life-threatening medical conditions.
- •6.Cases with suicidal ideation 7.Pregnant and lactating women.
结局指标
主要结局
DERS (Difficulties in Emotion Regulation Scale) will be administered in baseline and monthly for 12 months to evaluate the effectiveness of individualized homoeopathic medicines in reducing difficulties in emotion regulation in alcohol-dependent individuals with AUDIT score above 13 in women and above 15 in men and having DERS-SF(DERS-Short Form) total score of 39 or more. The aim is to observe a reduction in the DERS score, indicating an improvement in emotion regulation after giving individualized homoeopathic medicines.
时间窗: Every monthly for 12 months ( Baseline and monthly 12 months )
次要结局
- PACS – Penn Alcohol Craving Scale will be administered monthly to evaluate the effectiveness of individualized homoeopathic medicines in reducing alcohol craving in alcohol-dependent individuals. The aim is to observe a reduction in the PACS score, indicating a decrease in alcohol craving(Baseline and every monthly for 12 months)
- • SADQ - Severity of Alcohol Dependence Questionnaire will be administered every three months to evaluate 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.(Once in every three months in 12 months ( Baseline, 3rd, 6th, 9th and 12th month ))
研究者
Dr Syed Sameer S
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala