A comparative clinical study to evaluate the tranquilizing effect of yastimadhu ksheera paka and kushmanda rasayana granules in artists with social phobia.
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment will be done by scoring subjective parameters by assessing on 0th, 14th and 28th day.
概览
简要总结
This is Raandomised open labelled parallel group study comparing the safety and efficacy of the trial drug Group A – Yastimadhu Ksheera Paka1pala before food morning Group B – Kushmanda Rasayana Granules12grams with milk on empty stomach early morning for 28 days in each group and study will be conducted in Shri Dharmasthala Manjunatheshwara college of Ayurveda Kuthpady Udupi, Karnataka, India. The primary measures will be assessed through Severity Measure for Social Anxiety Disorder (Social Phobia). According to American psychiatric association, Hamilton’s Anxiety Rating Scale, Manasika bhava scale. The secondary outcome majors will be assessed based on the WHO Quality of life Scale-Brief hence the study is an effort to prove the efficacy of Yastimadhu Ksheera Paka and Kushmanda Rasayana Granules in artists with social phobia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject fulfilling the DSM-5 Diagnostic criteria [for Social Phobia].
- •2.Artists – stage performers (Dancers, Singers, musician, debate, pick and speak, pick and act) 3.Age group: 18 -30yrs 4.Participants who are willing and able to provide informed consent.
排除标准
- •Subjects suffering from any other psychiatric and any organic disorders, lactating and pregnant Women will be excluded.
结局指标
主要结局
Assessment will be done by scoring subjective parameters by assessing on 0th, 14th and 28th day.
时间窗: Observation will be done on 0th , 14th and 28th day
Severity Measure for Social Anxiety Disorder (Social Phobia). According to American psychiatric association.
时间窗: Observation will be done on 0th , 14th and 28th day
Hamilton’s Anxiety Rating Scale.
时间窗: Observation will be done on 0th , 14th and 28th day
WHO Quality of life Scale-Brief.
时间窗: Observation will be done on 0th , 14th and 28th day
Manasika bhava scale
时间窗: Observation will be done on 0th , 14th and 28th day
Scored parameters will be analysed statistically after the treatment. All the subjective parameters and scales will be assessed using Wilcoxon signed rank test within the groups and Mann-Whitney U test in between the groups.
时间窗: Observation will be done on 0th , 14th and 28th day
次要结局
- quality of life(0th and 28th day)
研究者
Dr Shantala S Bharbhari
Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady Udupi