Evaluation of the status of Jatharagni in newly diagnosed Patients of Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome is to evaluate the correlation between the status of Jatharagni and depression.
研究概览
简要总结
HYPOTHESIS Null hypothesis (H0)There is no statistically significant relationship between Agni and newly diagnosed depression in the study population.Alternative hypothesis (H1)There is a statistically significant relationship between Agni and newly diagnosed depression in the study population.AIMS AND OBJECTIVESAim To evaluate the status of Jatharagni in individuals, newly diagnosed with depression.Objectives To assess Jatharagni using a validated Agni Assessment Tool in both individuals newly diagnosed with depression and healthy controls.To diagnose depression in individuals using the DSM-5 criteria.To assess cognitive ability using the Clock Drawing Test in both individuals newly diagnosed with depression and healthy controls.Depression will be assessed using the Hamilton Depression Rating Scale (HDRS).Swasthya Assessment Scale will be used for evaluating the control group.Secondary objective: To establish the relationship between Agni and newly diagnosed depression.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants newly diagnosed with depression based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- •The diagnosis must be confirmed by a licensed psychiatrist, and the participants must have been diagnosed within the last seven days.
- •Cognitive Ability: Participants must demonstrate sufficient cognitive ability to understand and respond to study questions.
- •This will be assessed using the Clock Drawing Test, a brief cognitive screening tool, before inclusion.
- •Willingness to Participate: Participants must provide informed consent and agree to complete all study procedures and assessments.
- •Healthy Controls (for Control Group): Adults between the ages of eighteen and thirty-five years with no history of psychiatric disorders.
- •Participants must meet the criteria for good health status as determined by the Swasthya Assessment Scale of CCRAS.
- •Inclusivity: Participants will be included irrespective of their gender, socioeconomic status, or educational background.
排除标准
- •• Severe Psychiatric Disorders: Individuals with severe psychiatric disorders such as schizophrenia or bipolar disorder.
- •• Substance Abuse: Individuals with a history of substance abuse or dependence.
- •• Neurological Disorders: Individuals with diagnosed neurological conditions (e.g., Parkinson’s disease, multiple sclerosis, epilepsy) that could directly affect cognitive function.
- •• Chronic Illnesses: Individuals with chronic medical conditions (e.g., hypertension, diabetes, heart disease) that may indirectly influence cognitive function over time.
- •• Pregnancy and Lactation: Female participants who are currently pregnant or in the lactating period.
- •• Interfering Medications: Individuals currently taking medications known to interfere with depression treatment (e.g., certain antidepressants, and antipsychotics).
- •• Cognitive Impairment: Individuals demonstrating significant cognitive impairment as determined by the Clock Drawing Test, indicating they may be unable to reliably participate in the study.
结局指标
主要结局
The primary outcome is to evaluate the correlation between the status of Jatharagni and depression.
时间窗: 54 weeks
次要结局
- To compare the Jatharagni status between newly diagnosed depression patients and healthy controls.(To assess the overall health status of healthy controls using the Swasthya Assessment Scale of CCRAS.)
研究者
Barad Vatsal Harajbhai
J.S.Ayurveda Mahavidhyalaya