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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sri Dharmasthala Manjunatheshwara Ayurvedic Medical College
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- 1) improvements noticed based on CAPS-5 Scale 2) improvements noticed in the Madonmada symptom scale
Overview
Brief Summary
This study is being undertaken with following objectives:
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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.
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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.
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To determine the efficacy of Satvavajaya chikitsa as monotherapy in the management of Post Traumatic Stress Disorder as compared to Madonmada.
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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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1) improvements noticed based on CAPS-5 Scale 2) improvements noticed in the Madonmada symptom scale
Time Frame: 5 years
Secondary Outcomes
- 1) IMPROVEMENTS noticed in the WHOQOL scale 2) improvements noticed in the Manobhava scale(5 years)
Investigators
Dr Ashwini S G
SDM college of Ayurveda,