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CTRI Number  CTRI/2019/05/019140 [Registered on: 15/05/2019] Trial Registered Prospectively
Last Modified On: 11/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To assess the combined effect of Shirodhara, Kalyanaka ghrta and Satvavajaya Chikitsa {Counselling} in Social Anxiety Disorder. 
Scientific Title of Study   A Clinical Study to assess the combined effect of Shirodhara, Kalyanaka Ghritha and Satvavajaya Chikitsa in reducing the symptoms of Social Anxiety Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neeraja M A 
Designation  PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Kayachikitsa Amrita School of Ayurveda Amrita Vishwa Vidyapeedam Clappana PO Kollam Kerala India 690546

Kollam
KERALA
690546
India 
Phone  8606404661  
Fax    
Email  niaaa8053@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahesh C Kundagol 
Designation  Associate Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Kayachikitsa Amrita School of Ayurveda Amrita Vishwa Vidyapeedam Clappana PO Kollam Kerala India 690546

Kollam
KERALA
690546
India 
Phone  9633549822  
Fax    
Email  maheshkund@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mahesh C Kundagol 
Designation  Associate Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Kayachikitsa Amrita School of Ayurveda Amrita Vishwa Vidyapeedam Clappana PO Kollam Kerala India 690546

Kollam
KERALA
690546
India 
Phone  9633549822  
Fax    
Email  maheshkund@yahoo.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda Amrita Vishwa Vidyapeedam Clappana PO Kollam Kerala India 690546 
 
Primary Sponsor  
Name  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda Amrita Vishwa Vidyapeedam Clappana PO Kollam India 690546 
Type of Sponsor  Private medical college 
 
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 
Dr Neeraja M A  Amrita School of Ayurveda  Department of Kayachikitsa Amrita school of Ayurveda Clappana PO Kollam 690546
Kollam
KERALA 
8606404661

niaaa8053@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIMS 2018 AYUR 243  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F418||Other specified anxiety disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable   Not applicable 
Intervention  Shirodhara, Kalyanaka ghrita and Satvavajaya Chikitsa  Pacana Deepana will be administered on OP basis with Vaishwanara Choorna (12gm) in a divided dosage with hot water and Gandharvahastadi Kashaya (48 ml dosage) with a pinch of saindhava (Rock salt) and jaggery before food twice daily for 1-7 days. Then patient will be admitted to the ward and Shirodhara will be administered with Balaguduchyadi Taila (8th- 14th day). Simultaneously Satvavajaya chikitsa (8th -14th day) and Kalyanaka Ghritha (48 ml) in a divided dosage before food as Samanoushada for (8th -30th day).  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients fulfilling the diagnostic criteria for Social Anxiety Disorder as per DSM 5 Diagnostic criteria.
Age between 20 to 60 years.
Patients with either gender irrespective of socioeconomic status
Patients willing to join the study and sign the informed consent form.
 
 
ExclusionCriteria 
Details  Patients with other psychiatric disorders
Pregnant women, Lactating mothers and children.
Patients with metabolic disorders and other systemic disorders
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
DSM 5 Assessment Criteria  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
DSM 5 Assessment Criteria  30 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/05/2019 
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="4"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

   Background:  Social Anxiety disorder [SAD] is a prevalent anxiety disorder characterized by significant amount of fear in one or more social situations which is persistent, typically lasting for 6 months or more. According to DSM 5, its prevalent rate decreases with age, more in adolescents than in young adults. In general, higher rates of social anxiety disorder is found in females than in males in the general population. The 12 month prevalence for older adults ranges from 2% to 5%. The present day management of Social Anxiety Disorder involves usage of anxiolytics and their use is limited owing to the risk of drug abuse and dependence. 

             Ayurveda is a science of life and gives equal significance to physical, mental, social and spiritual health. In the life time, one may suffer from physical, mental and spiritual ailments of which the Acharya’s have elaborately mentioned in classical texts (Samhitas). Based on the symptoms of SAD, there are similar references in Bhagavat Gita and Visadhata lakshana from Ashtangahrdaya. It refers to the Udvega Avastha of Manas (excited state of mind) which is caused by vitiated Rajas and having the predominance of Vata and Pitta Dosha.

             Shirodhara is considered the best therapy for diseases pertaining to the head, eye and ear, gives good sleep and which helps in relieving stress and Vata Vrddhi symptoms and that of Social Anxiety Disorder. Kalyanaka Ghritha mentioned in Charaka Samhitha, Unmada Chikitsa, is having Medhya property so it is selected as the Samanoushada for Social Anxiety Disorder. Satvavajaya Chikitsa provides Dhi, Dhairya, Atma jnana and Asvasana to the patient. This study aims to explore safe, effective and economical management of SAD following the therapeutic principles of Ayurveda. 


Objective:   To find out the combined effect of Shirodhara, Kalyanaka ghritha and Satvavajaya Chikitsa in reducing the symptoms of Social Anxiety Disorder using DSM-5 Assessment Scale.


Study Design: It will be a single group clinical study with pre and post-test study Design. 20 Patients who fulfil the inclusion criteria will be taken. Patient will be evaluated according to Diagnostic and Statistical Manual of Mental Disorders Assessment Criteria and the following treatment will be given.


Method:  Pacana Deepana will be administered on OP basis with Vaishwanara Choorna (12gm) in a divided dosage with hot water and Gandharvahastadi Kashaya (48 ml dosage) with a pinch of saindhava (Rock salt) and jaggery before food twice daily for 1-7 days. Then patient will be admitted to the ward and Shirodhara will be administered with Balaguduchyadi Taila (8th- 14th day). Simultaneously Satvavajaya chikitsa (8th -14th day) and Kalyanaka Ghritha (48 ml) in a divided dosage before food as Samanoushada for (8th -30th day).

           


 
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