AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE ENHANCED EFFECT OF SATVAVAJAYA CHIKITSA WITH SHANKHAPUSHPI (CONVOLVULUS PLURICAULIS) CAPSULE IN BODY DYSMORPHIC DISORDER W.S.R TO CHINTA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 2) Ham- A scale
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- Shankhapushpi Capsule (500 mg) 2 TID, Before Food with warm water and Group B– Shannkhapushpi Capsule (500 mg) 2 tid, Before Food with warm water and Satvavajaya Chikitsa once daily 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 throughAppearance anxiety Inventory for body dysmorphic disorder by Cambridge University of press and assessment , Manasika Bhava scale. Hence, the study is an effort to prove the efficacy and compare the effect of Shankhapushpi capsules and Shankhapushpi capsule along with Satvavajaya Chikitsa in Body Dysmorphic 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 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals fulfilling diagnostic criteria of Body Dysmorphic Disorder as per DSM-5 2)Achintana, Atichintana 3)Patients are selected of age group between 18-40 years 4)Patients willing to sign informed consent.
排除标准
- •Patients suffering from any systemic illness, psychiatric illness or any other metabolic disorders interfering with the treatment protocol 2)Pregnant and lactating women 3)Patient suffering from substance abuse.
结局指标
主要结局
2) Ham- A scale
时间窗: Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
3) WHO Quality of life scale
时间窗: Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
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 and 14th day (at 2 weeks)
4) Manobhava scale
时间窗: Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
All the subjective
时间窗: Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
parameters and scales will be assessed statistically using Wilcoxon signed rank test within the groups and
时间窗: Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
Parameters will be assessed on Day 0 and Day 14 using standard tools
时间窗: Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
1) Appearance Anxiety Inventory for BDD(Cambridge university)
时间窗: Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
次要结局
未报告次要终点