Efficacy of Homoeopathic Medications for the Treatment Of Depression utilizing HDR SCALE AND PHQ-9 SCALE in Early Adulthood: A Randomized, Single-Blind, Prospective, Unicentric, Interventional Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To find the efficacy of Homoeopathic medications in the treatment of depression in early adulthood.
研究概览
简要总结
This is a randomised, prospective, interventional study to understand efficacy of homoeopathic medicines in treatment of depression in early adulthood. Primary objective is to understand is there any clinical significance of homoeopathic medications in treatment of depression in early adulthood. Secondary objective is to understand the acceptability of homoeopathic treatment for depression. Patient satisfying the inclusion criteria will be enrolled into two groups using computer randomisation. Group A will receive homoeopathic intervention and group B will receive placebo. A minimum of 60 patients will be enrolled. Duration of the treatment will be of 6 months with follow up every 2 weeks. The diagnosis and the assessment of the patients will be done using HDR Scale and PHQ9 Scale. A discontinuation criteria assessment and outcome assessment will be carried out during each follow up. The pre and post study scores of all patients will be analyzed using statistical test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Case Definition.
- •The following signs and symptoms if present nearly every day for at least 2 weeks or more: Persistent sad, anxious, or “empty†mood Feelings of hopelessness, pessimism Feelings of guilt, worthlessness, helplessness Loss of interest or pleasure in hobbies and activities Decreased energy, fatigue, being “slowed down†Difficulty concentrating, remembering, making decisions Difficulty sleeping, early-morning awakening, or oversleeping Appetite and/or unwanted weight changes Thoughts of death or suicide; suicide attempts Restlessness, irritability Persistent physical symptoms, such as muscle pain or headaches.
- •Patients assessed using both HDR and PHQ9 Scale with the values of HDR Scale Score.
- •greater than or equal to 10 and less than or equal to
- •PHQ9 Scale Score- greater than or equal to 5 and less than or equal to
- •Patients fulfilling scores of both scales simultaneously will only be considered.
- •Cases that fulfil the case definition along with assessment scores will only be included.
- •Patients irrespective of socio-economic status.
- •Patients already diagnosed with depression but not under any medications.
- •Patients with washout period of more than 6 months but satisfy case definition.
排除标准
- •Age group of below 18 years and above 30 years.
- •Patients not fulfilling the case definition.
- •Patients who do not satisfy the assessment scores or the scores are only valid in one of the scales used for assessment.
- •Patient already diagnosed and under treatment for depression.
- •Patient under anti-psycotic or anti-depressant drugs.
- •Patient who need emergency medical or surgical intervention.
- •Patients diagnosed with severe depression, depression associated with other medical conditions like cancer, bipolar disorders, anxiety and other unspecified mood disorders and depression with psychotic symptoms like hallucinations.
- •Patients with washout period less than 6 months.
结局指标
主要结局
To find the efficacy of Homoeopathic medications in the treatment of depression in early adulthood.
时间窗: Follow up every 2 weeks for a period of 6 months.
次要结局
- To understand is there any clinical significance of homoeopathic medications in the treatment of depression in early adulthood.(Follow up every 2 weeks for a period of 6 months.)
研究者
Dr Sreya N
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre