An open-labelled, double-arm, Phase II clinical trial to evaluate the effectiveness of Kadukkai Karpam and Kadukkai Karpam with Thirumoolar Pranayamam in the management of Viyagula Unmatham with special reference to Depression.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary outcome of the trial will be reduction in depressive symptoms, assessed using a validated depression rating scale such as PHQ-9 questionnaire from baseline to the end of the intervention period.
研究概览
简要总结
It is an open labelled double arm Randomized phase ll clinical trial to evaluate the effectiveness of Kadukkai karpam (Internal Medicine) and Kadukkai Karpam (Internal Medicine) with Thirumoolar Pranayamam (Siddhar Thirumoolar Breath Technique).
Group A will be given oral administration of 3 grams of internal medicine Kadukkai karpam once a day in evening time with water and
Group B will also be given Oral administration of 3 grams of medicine once a day in evening time with water along with practice of Thirumoolar Pranayamam technique for a duration of 45 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Hamilton Depression Rating Scale (HAMD-17) score of 18 or more
- •Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 45 days but can opt out of the trial of his/her own conscious discretion.
排除标准
- •Any co morbid psychiatric illness especially bipolar depression, schizophrenia or dementia
- •Suicidal intent or any other psychiatric emergency
- •Evidence of other medical comorbidity that could substantially influence depression or has an effect on cognition and behavior
- •History of alcohol or drug abuse over the last 6 months
- •Anti-epileptic drugs
- •Pregnancy or Post-partum women.
- •Acute infectious diseases
- •Ongoing current practice of yoga or any other mind-body techniques.
- •Pre existing Cardiac illness, severe lung illness.
结局指标
主要结局
The primary outcome of the trial will be reduction in depressive symptoms, assessed using a validated depression rating scale such as PHQ-9 questionnaire from baseline to the end of the intervention period.
时间窗: Baseline (0th day) and at the end of the intervention period (45th day)
次要结局
- This research explores the potential synergistic benefits of Thirumoolar Pranayamam as an addon intervention with Kadukkai Karpam in enhancing therapeutic outcomes of Viyagula Unmatham with special reference to depression.(Baseline (0th day) and the end of the intervention period (45th day))