Individualized homoeopathic medicines in managing depression in middle-aged married individuals: 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
- 84
- 试验地点
- 1
- 主要终点
- DASS 21 Questionnaire - depression subscale
研究概览
简要总结
Depression is “a period of at least two weeks when a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had a majority of specified symptoms, such as problems with sleep, eating, energy, concentration, or self-worth.†This definition excludes grief after mourning . Stress is usually characterized by a sense of feeling overwhelmed. This feeling may be due to your coping capacity being over-stretched or having been under pressure for too long. Some stress can help us to perform our day-to-day functions, too much stress leaves us “distressed†and often exhausted . This double-blind randomized placebo-controlled trial intends to ascertain the probable significant treatment effect after using of Individualized Homoeopathic Medicine along with standard care will be conducted on 84 participants suffering from depression in both the outpatient and in-patient departments of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Depression, anxiety and stress questionnaire [Primary outcome], Stockholm Marital Stress Scale (SMSC) and Measure Yourself Medical Outcome Profile v2 (MYMOP-2) [Secondary outcomes], to be measured at baseline and every month, up to 3 months. This double- blind, randomized (2:1), placebo-controlled, parallel group efficacy trial will be an attempt to compare the effects of IHM in centesimal potencies against placebo. Group differences will be calculated on the intention-to-treat and per-protocol approaches. 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
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with depression, anxiety and stress for at least 2 weeks (DSM V & ICD 11-Code 6A73).
- •Middle-aged married individuals i.e., 40 – 60 years.
- •Mild and moderate depression [DASS-10 mild: 6, moderate 7-12; DASS-21: 10-20 (mild to moderate depression), 8-14 (mild to moderate anxiety), 15-25 (mild to moderate stress).
- •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
- •Not providing with written informed consent
- •Mood disturbance when associated with bipolar affective disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder with suicidal tendency.
- •Currently receiving any effective anti-depressant.
- •Any life-threatening diseases on recently active physical disease.
- •In some condition when requiring emergency or surgical intervention.
- •Depression due to some organic disease or physiological effects of any medicine, hysterectomy and receiving any kind of hormone therapy.
- •Presence of medical conditions such as uncontrolled diabetes Mellitus Type 2, uncontrolled hypertension, uncontrolled hypothyroidism.
- •Pregnancy, puerperium, lactating women.
- •History of myocardial infarction, stenting, coronary artery bypass surgery or stroke.
- •Undergoing homoeopathic treatment for any chronic disease within last six months.
- •Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, mentally incompetent people.
- •Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
DASS 21 Questionnaire - depression subscale
时间窗: Baseline, every month, up to 3 months
次要结局
- DASS 21 Questionnaire - Anxiety subscale(Baseline, every month, up to 3 months)
- DASS 21 Questionnaire - Stress subscale(Baseline, every month, up to 3 months)
- Stockholm Marital Stress Scale(Baseline, every month, up to 3 months)
- Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2)(Baseline, every month, up to 3 months)
研究者
Aiswarya Tripathy
D N De Homoeopathic Medical College and Hospital