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
|
|
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
|
|
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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