Efficacy of individualized homoeopathic medicines in reducing geriatric depression: A double blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS 17)
研究概览
简要总结
Geriatric depression is a term used to describe a depressive episode that affects people beyond the age of sixty. A prevalence rate of 17.1% for clinically severe depression symptoms was found in this age group by meta-analyses. One of the most prevalent ailments for which people seek homoeopathic treatment is depression. An extensive search for both published and unpublished research has shown that the dearth of high-quality clinical trials has restricted the data supporting homeopathy’s efficacy in treating depression. It is necessary to do additional research, which should involve carefully planned controlled trials with an adequate number of people. This double-blind, randomized, placebo-controlled trial on 54 patients suffering from geriatric depression intends to ascertain the probable efficacy of individualized homoeopathic treatment versus placebo. Assessment will be done by Hamilton Depression Rating Scale (HDRS) [Primary outcome], Geriatric Depression Scale 15(GDS-15) [Secondary outcome], Measure Yourself Medical Outcome Profile version2.0 (MYMOP-2) [Secondary outcome] to be measured at baseline and every month, up to 3 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •A. Elderly people with depression of not less than two weeks duration, with a minimum of two typical and two common symptoms will be included in the study. • Typical symptoms: o Depressed mood o Loss of interest and enjoyment. o Increased fatigability and diminished activity • Common symptoms: o Reduced concentration and attention. o Reduced self-esteem and self-confidence. o Guilt feeling and unworthiness (mild type of episode) o Bleak and pessimistic view of the future. o Disturbed Sleep o Diminished appetite B. Age above 60 years C. Mild and moderate depression [HDRS score.
- •8-13 mild, 14-18 moderate] D. GDS-15 score more than 5 E. Participants having prior experience or knowledge of the treatment; e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •Mood disturbance when associated with bipolar affective disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder.
- •Severe dementia (MoCA score less than 10) C.
- •Currently receiving any effective anti-depressant.
- •Active suicidal E.
- •Uncontrolled systemic disorders.
- •Undergoing homoeopathic treatment for any chronic disease within the last six months.
- •Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •Self-reported immune-compromised state.
- •Patients with the habit of tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence.
- •Simultaneous participation in any other clinical trials K.
- •Not Providing with written informed consent to participate voluntarily.
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS 17)
时间窗: Baseline, every month, up to 3 months
次要结局
- Geriatric Depression Scale 15 (GDS-15)(Baseline, every month, up to 3 months)
- Measure Yourself Medical Outcome Profile-2 (MYMOP-2)(Baseline, every month, up to 3 months)
研究者
Dr Anandita Ray
D. N. De Homoeopathic Medical College and Hospital