A Comparative Clinical Study Evaluating the Efficacy of Satvavajaya Chikitsa in combination with Medhya dravya administered Orally and Nasally in Post Traumatic Stress Disorder Vis-a-Vis Madonmada.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1) improvements noticed based on CAPS-5 Scale 2) improvements noticed in the Madonmada symptom scale
研究概览
简要总结
This study is being undertaken with following objectives:
-
To determine the Efficacy of Brahmi Grita Pratimarsha Nasya followed by Yastimadhu varti Dhoomapana nasally with satvavajaya chikitsa as combined therapy in the management of Post Traumatic Stress disorder as compared to Madonmada.
-
To determine the efficacy of Chaturmeda Rasayana capsules orally with Satvavajaya chikitsa as combined therapy in management of post traumatic stress disorder as compared to madonmada.
-
To determine the efficacy of Satvavajaya chikitsa as monotherapy in the management of Post Traumatic Stress Disorder as compared to Madonmada.
-
To compare the efficacy of combined therapy with brahmi ghrita pratimarsha nasya followed by Yastimadhu varti dhoomapana with satvavajaya chikitsa and chaturmedhya rasayana capsules orally with satvavajaya chiktsa and satvavajaya as monotherapy in the management of Post Traumatic Stress Disorder as compared to Madonmada.
Hypothesis of this study are:
H0: there is no significant difference in the effect of combined therapy with brahmi ghrita pratimarsha nasya followed by Yastimadhu varti dhoomapana with satvavajaya chikitsa and chaturmedhya rasayana capsules orally with satvavajaya chiktsa and satvavajaya as monotherapy in the management of Post Traumatic Stress Disorder as compared to Madonmada.
H1:There is significant effect of Brahmi Grita Pratimarsha Nasya followed by Yastimadhu varti Dhoomapana nasally with satvavajaya chikitsa as combined therapy in the management of Post Traumatic Stress disorder as compared to Madonmada.
H2: There is a significant effect of Chaturmeda Rasayana capsules orally with Satvavajaya chikitsa as combined therapy in management of post traumatic stress disorder as compared to madonmada.
H3: There is a significant effect of Satvavajaya chikitsa as monotherapy in the management of Post Traumatic Stress Disorder as compared to Madonmada.
H4: There is significant difference in the effect of combined therapy with brahmi ghrita pratimarsha nasya followed by Yastimadhu varti dhoomapana with satvavajaya chikitsa and chaturmedhya rasayana capsules orally with satvavajaya chiktsa and satvavajaya as monotherapy in the management of Post Traumatic Stress Disorder as compared to Madonmada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of PTSD as per DSM-
- •Subjects with mild and moderate severity of disease will be included.3) Subjects belonging to either sex irrespective of socioeconomic status and caste.
- •Subjects willing to give to consent for the proposed programme and fit to follow all the study protocols.
- •patients in whom ongoing medications will not be contradictory to therapy.
排除标准
- •subjects with advanced psychotic disorders like schizophrenia, dementia, suicidal behavioral, manic disorders will be excluded.2) Subjects with history of substance abuse.
- •subjects with uncontrolled systemic illness with or deformity such as cardiac disorders, uncontrolled diabetes mellitus with complications, systemic hypertension, end stage renal disease, liver failure, auto immune diseases of joints and subjects diagnosed with malignant tumors, HIV, HBsAG, Tuberculosis and others.
- •Pregnant and lactating women.
结局指标
主要结局
1) improvements noticed based on CAPS-5 Scale 2) improvements noticed in the Madonmada symptom scale
时间窗: 5 years
次要结局
- 1) IMPROVEMENTS noticed in the WHOQOL scale 2) improvements noticed in the Manobhava scale(5 years)
研究者
Dr Ashwini S G
SDM college of Ayurveda,