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CTRI Number  CTRI/2025/03/082702 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study to know the effect of Satvavajaya (counselling therapy), Medhya Dravya (medicine promoting intellectual wellbeing) orally and nasally (medicinal drops) in Madonmada also known as Post Traumatic Stress disorder. 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwini S G 
Designation  Assistant professor 
Affiliation  SDM college of Ayurveda,  
Address  DEPARTMENT OF KAYACHIKITSA Aroor Laxminarayan Rao Memorial Ayurvedic Medical College, Koppa, Chikmagalur.
Kuthpady, Udupi.
Udupi
KARNATAKA
577126
India 
Phone  9886685202  
Fax    
Email  drashung@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijayendra G Bhat 
Designation  Associate professor 
Affiliation  SDM college of Ayurveda,  
Address  DEPARTMENT OF KAYACHIKITSA and Manasaroga, SDM COLLEGE OF AYURVEDA, KUTHPADY, UDUPI
Kuthpady Udupi.
Udupi
KARNATAKA
574118
India 
Phone  9448139919  
Fax    
Email  ayurvijay25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini S G 
Designation  Assistant professor 
Affiliation  SDM college of Ayurveda,  
Address  DEPARTMENT OF KAYACHIKITSA Aroor Laxminarayan Rao Memorial Ayurvedic Medical College, Kachkal raod, Koppa, Chikmagalur
Kuthpady, Udupi.
Udupi
KARNATAKA
577126
India 
Phone  9886685202  
Fax    
Email  drashung@gmail.com  
 
Source of Monetary or Material Support  
Aroor Laxminarayan Rao Memorial Ayurvedic Medical College, Kachkal Road, Koppa, Chikmagalur. 577126 
Sri Dharmasthala Manjunatheshwara Ayurvedic Medical College, Kuthpady Udupi, Karnataka, India. 574118 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara Ayurvedic Medical College 
Address  Kuthpady, Udupi, Karnataka , India. 574118 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Aroor Laxminarayan Rao Memorial Ayurvedic Medical College  Kachkal Road, Koppa, Chikmagalur.577126 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashwini S G  Aroor Laxminarayan Rao Memorial Ayurvedic Medical College  Assistant Professor, Department of kayachikitsa, Kachkal Road, Koppa, Chikmagaluru, Karnataka, India 577126.
Chikmagalur
KARNATAKA 		 9886685202

drashung@gmail.com 
Dr Ashwini S G  Sri Dharmasthala Manjunatheshwara Ayurvedic Medical College   PhD scholar, Department of Kayachikitsa, Kuthpady, Udupi, karnataka, India 574118
Udupi
KARNATAKA 		 9886685202

drashung@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F431||Post-traumatic stress disorder (PTSD). Ayurveda Condition: MADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Brahmi gritha, Reference: AFI, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 49 Days, anupAna/sahapAna: Yes(details: yastimadhu varti dhoomapana 2 sets of 3 bouts each time daily once after nasya ref astanga hridaya), Additional Information: this drug intervention done along with satvavajaya chikitsa once weekly for 7 weeks
2Intervention ArmDrugClassical(1) Medicine Name: chaturmedhya rasayana , Reference: charaka samhuta rasayana adhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 49 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: this intervention will be administered with satvavajaya chikitsa weekly once for 7 weeks
3Comparator ArmProcedure-satvAvajaya-cikitsA, सत्वावजय-चिकित्सा (Procedure Reference: modern counselling therapy, Procedure details: according to signs & symptoms of PTSD & madonmada, a suitable satvavajaya chikitsa will be designed for each patient with reference to contemprary counselling techniques adopted to ayurvedic principles targeting jnana (insight oriented approach), vijnana (educative approach), dhairya (supportive approach), smriti (cognitive approach), samadhi (psycho-philosophical approach))
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Diagnosed cases of PTSD as per DSM-5. 2) Subjects with mild and moderate severity of disease will be included.3) Subjects belonging to either sex irrespective of socioeconomic status and caste. 4) Subjects willing to give to consent for the proposed programme and fit to follow all the study protocols. 5) patients in whom ongoing medications will not be contradictory to therapy. 
 
ExclusionCriteria 
Details  1) subjects with advanced psychotic disorders like schizophrenia, dementia, suicidal behavioral, manic disorders will be excluded.2) Subjects with history of substance abuse. 3) 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. 4) Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) improvements noticed based on CAPS-5 Scale 2) improvements noticed in the Madonmada symptom scale  5 years 
 
Secondary Outcome  
Outcome  TimePoints 
1) IMPROVEMENTS noticed in the WHOQOL scale 2) improvements noticed in the Manobhava scale  5 years 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drashung@gmail.com].

  6. For how long will this data be available start date provided 05-10-2025 and end date provided 05-10-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is being undertaken  with following objectives:
1) 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.
2) 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.
3) To determine the efficacy of Satvavajaya chikitsa as monotherapy in the management of Post Traumatic Stress Disorder as compared to Madonmada.
4) 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.
 
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