An open label comparative clinical study to evaluate the enhanced effect of Guided imagery meditation with Tulsi (Ocimum sanctum Linn) capsule on professional students in Chittodvega w.s.r to Adjustment disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Parameters will be scored by standard method and will be assessed before and after
研究概览
简要总结
This is a randomised open label parallel group study comparing the safety and efficacy of the trial drug Group A- Tulsi Capsule (500 mg) 2 BD, Before Food with
warm water and Group B– Tulsi Capsule (500 mg) 2 BD, Before Food with warm water and Guided imagery meditation once daily for 10 mins for a period of 14 days. The study will be conducted in Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. The primary measures will be assessed through Student adaptation to college questionnaire by Baker and Siryk, Hamiltons anxiety rating scale, Manasika Bhava scale. Hence, the study is an effort to prove the efficacy and compare the effect of Tulsi capsules and Tulsi capsule along with Guided imagery meditation in professional students with Adjustment disorder.
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 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are professional students fulfilling diagnostic criteria of Adjustment Disorder as per DSM-
- •Subjects are selected of age group between 18-30years.
- •Subjects willing to sign informed consent.
排除标准
- •Subjects suffering from any systemic illness, psychiatric illness or disorder interfering with the treatment protocol.
- •Subjects suffering from substance abuse, cicardian rhythm disorder.
结局指标
主要结局
Parameters will be scored by standard method and will be assessed before and after
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
treatment on 0th , 14th day.
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
1) Student adaptation to college Questionnaire by Baker & Siryk
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
2) Hamilton’s Anxiety rating scale
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
Statistical analysis:
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
the subjective parameters and scales will be assessed using Wilcoxon signed rank test
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
3) Manasika Bhava scale.
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
All scored parameters will be analyzed statistically after the treatment on 14th day. All
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
within the groups and Mann-Whitney U test in between the groups.
时间窗: Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
次要结局
未报告次要终点