| CTRI Number |
CTRI/2024/05/068044 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Pranayama Gayatri Mantra and Sadbhavana Mantra on Generalized Anxiety Disorder
|
|
Scientific Title of Study
|
Effect of Pranayama Gayatri Mantra and Sadbhavana Mantra on Chittodwega (Generalized Anxiety Disorder) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nigam Devi |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7505991852 |
| Fax |
|
| Email |
nigamsaini1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parameswarappa S. Byadgi |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parameswarappa S. Byadgi |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India,221005
|
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda IMS |
| Address |
Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India 221005 up |
| Type of Sponsor |
Government 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 Parameswarappa S Byadgi |
Institute of Medical Sciences, Sir Sunder Lal Hospital |
Room No. 23, Indian Medicine Wing, Sir Sunder Lal Hospital, Institute of Medical Sciences, Varanasi
Uttar Pradesh, India
Varanasi
UTTAR PRADESH |
9450711759
psbyadgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gayatri mantra +Clonazepam |
Gyatri Mantra 10 minutes and Clonazepam 0.25MG for 60 days |
| Intervention |
Paranayama +Clonazepam |
Bhramari Pranayama 5 minutes Nadi Sodhan Pranayama 5 minutes and Clonazepam 0.25MG for 60 days |
| Comparator Agent |
Sadbhavana mantra + Clonazepam |
Sadbhavana Mantra 10 minutes and
Clonazepam 0.25MG for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged between 18 to 40 years of both male and female.
Subject who fulfilled the diagnostic criteria of Generalized Anxiety Disorder as per
ICD-11.
The patient who is willing to participate in the research work after giving informed
written consent in a predesigned proforma. |
|
| ExclusionCriteria |
| Details |
Subject less than 18 and more than 40 years.
Subject who are suffering from chronic psychiatric condition.
Persons who are not able to perform Pranayama, Gayatri Mantra & Sadbhavana
mantra. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the reduction the anxiety level in GAD . |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Generalized Anxiety Disorder 7-item (GAD-7) scale, Student’s Stress
Dimension Questionnaire (SSDQ) & Session Reactions Scale -3 Brief (SRS-3-B)
before and after Pranayama, Gayatri Mantra & Sadbhavana Mantra.
|
60 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="2"
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
|
In this study, 120 patients diagnosed with Generalized Anxiety Disorder (GAD) will be selected based on specific inclusion criteria and randomly divided into three groups. Each group will be instructed to engage in daily practices for a period of 60 days.
Patients will be provided with guidance and demonstrations in a dedicated ward to ensure proper execution of the practices. The first group will practice pranayama, the second group will recite the Gayatri mantra, and the third group will engage in reciting the sadbhavana mantra.
Before and after the 60-day intervention period, all participants will undergo investigations tailored to their individual needs. Additionally, each group will receive 10 minutes of relaxation before the intervention sessions. Furthermore, all three groups will have access to clonazepam 0.25MG for managing subjective anxiety symptoms on an as-needed basis.
The study aims to assess the effectiveness of these different practices in reducing symptoms of anxiety in patients with GAD, while also considering the potential impact on subjective well-being and overall mental health. |