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CTRI Number  CTRI/2025/08/093340 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Dhairya chikitsa]  
Study Design  Other 
Public Title of Study   Role of Dhairya chikitsa in Social Anxiety 
Scientific Title of Study   A Clinical Study To Analyse The Effect Of Dhairya Chikitsa In Social Anxiety (Chittodvega) 
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 Sharadhi A R Bhasri 
Designation  2nd year PG Scholar 
Affiliation  Alvas Ayurveda Medical College and Hospital 
Address  Department of PG studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College and Hospital Moodubidire DK Karnataka
Department of PG studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College and Hospital Moodubidire DK Karnataka
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9480959299  
Fax    
Email  sharadhiar99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raviprasad Hegde 
Designation  BAMS MD  
Affiliation  Alvas Ayurveda Medical College and Hospital 
Address  Associate Professor Department of PG studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College and Hospital Moodubidire DK Karnataka
Associate Professor Department of PG studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College and Hospital Moodubidire DK Karnataka
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9448623599  
Fax    
Email  raviprasadhegde@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sharadhi A R Bhasri 
Designation  2nd year PG Scholar 
Affiliation  Alvas Ayurveda Medical College and Hospital 
Address  Department of PG studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College and Hospital Moodubidire DK Karnataka
Department of PG studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College and Hospital Moodubidire DK Karnataka
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9480959299  
Fax    
Email  sharadhiar99@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr.Sharadhi A R Bhasri  
Address  Department of PG studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College and Hospital Moodubidire DK Karnataka  
Type of Sponsor  Other [Myself] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sharadhi AR Bhasri   Alvas ayurveda medical college and hospital Moodubidire Dakshina kannada  department of manovijnana evam manasaroga alvas ayurveda medical college and hospital moodubidire dakshina kannada karnataka 574227
Dakshina Kannada
KARNATAKA 
9480959299

sharadhiar99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethical commitee Alvas Ayurveda Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F401||Social phobias. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-satvAvajaya-cikitsA, सत्वावजय-चिकित्सा (Procedure Reference: charaka samhita sutra sthana 11/54 and 1/58,ashtanga hridaya sutra sthana 1/26, Procedure details: Minimum of 30 research participants are selected for the study are given Satwavajaya Chikitsa. Satwavajaya Chikitsa is designed based on classical reference & modern literature. Those who are fulfilling diagnostic criteria will be given Satwavajaya Chikitsa for 30 minutes, in the form of Dhairya Chikitsa, once in a week for 30 days )
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Research participants specifying the diagnostic criteria of Performance Anxiety under Social Anxiety is considered 
 
ExclusionCriteria 
Details  Research participants suffering from any other psychiatric diseases
Research participants suffering from systemic diseases
Research participants those who are not willing to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of Dhairya chikitsa in Social Anxiety through kutchers generalized social anxiety disorder scale for adolescents  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/09/2025 
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="1"
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 - NO
Brief Summary  
NEED FOR THE STUDY

Chittodvega is a Manasa Vikara and seen due to vitiation of Rajas and Tamas described by Charaka. The etymological derivation of the term seems to be anxious state of the mind  i.e, Anavastita Chetasa and it is one of Vataja Nanatmaja Vikara, also mentioned as Poorvaroopa of Unmada

Social Anxiety Disorder (SAD) is a persistent irrational fear of activities or social interaction in the presence of other people. The individual is afraid of his or her own actions being viewed by others critically resulting in embarrassment. It is least investigated and most misunderstood. 

The Global prevalence of Social Anxiety varies across from a range of 22.9-57.6%. In an international community survey across 13 different countries, magnitude of SAD was 4% and prevalence was higher for females 8% than for males 6.1%,

In ayurveda, get explanation about Dravya and Adravyabhuta Chikitsa for diseases related to Sharira and Manas,  Satwavajaya Chikitsa is one among Trividha Chikitsa, it helps in restraining the Manas ie, Manonigraha from Ahita Arthas, In Charaka Samhita Dhiarya has been mentioned as one of Satwavajaya chikitsa to potentiate Satwa to subdue the exaggerated Tamas, Rajas by boosting confidence, assurance, determination and maintainance of mental balance even under stress

Being the 3rd most common mental health disorder after depression and alcohol abuse, This problem among adolescents needs cost effective, drugless therapy. Hence clinical study is to be conducted to know the effect of Dhairya Chikitsa in management of Chittodvega.

REVIEW OF LITERATURE

Chittodvega is one among the Manovikaras and is first explained by Acharya Charaka in Vimana Sthana 6/5.

Acharya Sushruta described Udvega as Poorvaroopa of Unmada and one among the symptoms of Bhutabhisangaja Jwara.

Acharya Dalhana described Chittodvega while defining the Shoka i.e. Putradi viyoge

chittodvega in Sushruta Samhita Sutra Sthana 1/25(3).

There is reference of Chittopaplava in Ashtanga Hridaya Nidana Sthana 6/2-3.

Satwavajaya Chikitsa is one among Trividha Aushada explained by Charaka Acharya in Sutra Sthana 11/54 and 1/58 and Vagbhata Acharya in Sutra Sthana 1/26.

Social Anxiety Disorders will be reviewed from Kaplan and Sadock’s Comprehensive Textbook of Psychiatry by Benjamin James Sadock, Virginia Alcott Sadock and Pedro Ruiz, Kaplan and Sadock’s Concise Textbook of Clinical Psychiatry by Benjamin James Sadock and Virginia Alcott Sadock. Diagnostic and Statistical Manual of Mental Disorders DSM V by American Psychiatric Association, Essentials of Psychiatry by M.S Bhatia.

Psychotherapy will be reviewed from Theory and Practice of Counselling and Psychotherapy by Gerald Corey, Counseling Psychology by Charles J Gelso and Bruce R Fretz, Counselling and Guidance by S Narayana Rao and Prem Sahaj pal, Psychiatry Mentor by Michael R Privitera and Jeffrey M Lyness, Kaplan and Sadock’s Synopsis of Psychiatry by Benjamin James Sadock, Virginia Alcott Sadock and Pedro Ruiz, Interviewing Strategies For Helpers by Sherry and Bill cormier, Self-Instructional Material For M.S In Counselling and Psychotherapy by Manasa Educational Foundation For Mental Health.

AIMS AND OBJECTIVES OF THE STUDY

AIM

To find cost effective therapy in the management of Social Anxiety (Chittodvega).

OBJECTIVES

To evaluate the effect of Dhairya Chikitsa in management of Social Anxiety (Chittodvega).

To understand the concept of Satwavajaya Chikitsa and to study the influence of Dhairya Chikitsa in Social Anxiety (Chittodvega).

 HYPOTHESIS

Ho There is no statistically significant effect of Dhairya Chikitsa in Social Anxiety (Chittodvega).

H1  There is statistically significant effect of Dhairya Chikitsa in Social Anxiety (Chittodvega)

PROCEDURE

 Minimum of 30 research participants are selected for the study are given Satwavajaya Chikitsa.

 Satwavajaya Chikitsa is designed based on classical reference and modern literature.

 Those who are fulfilling diagnostic criteria will be given Satwavajaya Chikitsa for 30 minutes, in the form of Dhairya Chikitsa, once in a week for 30 days.

STUDY DURATION: 30 days.

 OBSERVATION PERIOD

Assessment will be done by scoring the gradations on 1st day, later on 15th day to assess the progress of disease and on 30th day including one performance/activity.

ASSESSMENT CRITERIA

Diagnosis and assessment of signs and symptoms of the condition will be assessed according to Kutcher’s Generalized Social anxiety disorder scale for adolescents (K-GSADS-A).

 
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