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临床试验/CTRI/2017/03/008078
CTRI/2017/03/008078招募中2/3 期

A double-blind, randomized, placebo-controlled efficacy trial of individualized homeopathic treatment of geriatric depression

MBHM College Hospital MHM College Hospital The CHM College Hospital3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年3月4日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
150
试验地点
3
主要终点
15-items short-form Geriatric Depression Score (translated Bengali version)

研究概览

简要总结

Depressionis the most common mental disorder in community settings, and is a major causeof disability across the world. In 1990, it was the fourth commonest cause ofloss of disability adjusted life years in the world, and by 2020, it isprojected to become the second commonest cause. A range of therapeutic approachesare available, the most widely used, in developed countries, is antidepressant drugs.Still, there still remain flaws in the treatment of depression withantidepressants, in terms of efficacy, adverse effects, toxicity overdose, non-complianceto treatment and delayed onset of their therapeutic response. Use of homeopathyto treat psychiatric problems is widespread, and the need for more high qualitycontrolled trials has been identified. Meta-analyses and systematic reviewshave drawn mixed conclusions as to whether homeopathy is more effective thanplacebo in general medicine. Theauthors undertook a cross-sectional validation survey, followed by open,observational trial involving 60 patients suffering from geriatric depression inthe geriatric outpatient of Midnapore Homeopathic Medical College &Hospital (MHMC&H), Govt. of West Bengal, India from May 2015 to April 2016using Geriatric Depression Scale (GDS). After3 months of treatment, moderate to large effect size was observed and the questionnaire psychometrics appearedsatisfactory. Theauthors intend to undertake a multicenter placebo-controlled double-blindrandomized efficacy trial of individualized homeopathic treatment on minimum150 patients suffering from geriatric depression at Midnapore HomoeopathicMedical College and Hospital (MHMC&H), Mahesh Bhattacharyya HomoeopathicMedical College and Hospital (MBHMC&H); and The Calcutta HomoeopathicMedical College and Hospital (CHMC&H). We hypothesize that individualizedhomeopathic treatment may produce effect significantly different from placeboin treatment of geriatric depression. The outcome measures are Geriatricdepression score questionnaire and Quality of Life Scale score questionnaire,to be measured at baseline and after 3 months. Intervention is planned asadministering indicated homeopathic remedies in centesimal potencies orplacebo, indistinguishable from verum. The generated results will be analyzedin the end using appropriate statistical tests and the results will bepublished in scientific research journals.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Aged 60-80 years, both sexes, and suffering from depression [Geriatric Depression Score: ≥ 5].

排除标准

  • Patients who are too sick for consultation, unwilling to take part, unable to read, and not giving consent to join the study, diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting QoL, currently receiving standard psychiatric therapy (conventional medication), chronic alcoholism, drug abuse and/or dependence, self-reported immune-compromised state, and undergoing homeopathic treatment for any chronic disease within last 6 months.

结局指标

主要结局

15-items short-form Geriatric Depression Score (translated Bengali version)

时间窗: At baseline and after 3 months

次要结局

  • 16-items Quality of Life Scale score (translated Bengali version)(At baseline and after 3 months)

研究者

发起方
MBHM College Hospital MHM College Hospital The CHM College Hospital
申办方类型
Government medical college

研究点 (3)

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