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CTRI Number  CTRI/2024/04/065801 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 25/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Effect of Bhramari Pranayama for Generalised Anxiety Disorder on Mental Health 
Scientific Title of Study   Efficacy Of Bhramari Kumbhaka on Mental Health W.S.R. To Chittodvega(Generalised Anxiety Disorder) - A Single Arm Clinical Trial 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jhanvi Sarvaiya  
Designation  MD Scholar  
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Swasthavritta, Dhanvantari Mandir, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9429585464  
Fax    
Email  jhanvisarvaiya25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Vd Arpan Bhatt  
Designation  Professor and Head  
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Room no. 5, Department of Swasthavritta, Dhanvantari Mandir, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9998968727  
Fax    
Email  vdarpansoniac@itra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prof Vd Arpan Bhatt  
Designation  Professor and Head  
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Room no. 5, Department of Swasthavritta, Dhanvantari Mandir, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9998968727  
Fax    
Email  vdarpansoniac@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar  
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Opposite Reliance Mart, Near B Division Police Station Gurudwara Road  
Type of Sponsor  Research institution and hospital 
 
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 
Jhanvi Sarvaiya  Institute of Teaching and Research in Ayurveda  OPD no. 12 Department of Swasthavritta and Yoga UG Campus Dhanwantari Mandir Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT 
9429585464

jhanvisarvaiya25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: Chittodvega ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Bhramari Kumbhaka (Procedure Reference: Swami Muktibodhananda Hatha yoga pradipika ;3rd edition 1998, reprinted-2006, Yoga Publication Trust, Bihar Chapter-2 verse-2, page-150, Procedure details: ●After the enrolment, individuals will be given instructions regarding the place where they have to be present wearing a precise dress code for 45 days. ●The session will be conducted twice daily. ●Starting with Prana Dharana in Sukhasana. It will be followed by Nadi Shodhana. Finally, 7 rounds of Bhramari Kumbhaka will be practiced for 15 days; it will be improved to 14 rounds for next 15 days and finally to 21 rounds for another 15 days. ●The method to perform Bhramari Kumbhaka will)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Individuals with the age between 18 to 60 years without any bar of age, sex, religion.
2.Patients with typical clinical findings suggestive of Chittodvega (GAD).
3.Chronicity less than one year
4.Patients rating mild to moderate (17 to 24) Hamilton Anxiety Rating Scale.
5.Patients not practicing or irregularly practicing Yoga, Bhramari Kumbhaka and Omkara Pranayama.
 
 
ExclusionCriteria 
Details  1.Patients below 18 years and above 60 years of age.
2.Patients who are not willing to participate in the study.
3.Patients who are detected with major psychological anomalies.
4.Patients practicing Yoga, Bhramari Kumbhaka and Omkara Pranayama regularly.
5.Patients rating more than 24 Hamilton Anxiety Rating Scale.
6.Chronicity more than one year.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
●Bhramari Kumbhaka will be effective in the management of Chittodvega (GAD).
●Reduction in sign and symptoms of Chittodvega.

 
45 Days
 
 
Secondary Outcome  
Outcome  TimePoints 
● Improvement in the Quality of Life.  45 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

EFFICACY OF BHRAMARI KUMBHAKA ON MENTAL HEALTH W.S.R. TO CHITTODVEGA (GENERALISED ANXIETY DISORDER) - A SINGLE ARM CLINICAL TRIAL

Introduction:

The classics have clarified that there are two sites of disease production viz. Sharira and Manas and it has also been understood that all the short or prolonged emotional changes like – Kama (passion), Krodha (Anger), Lobha (greed), Moha (confusion), Irshya (envy), Maana (conceit), Mada (arogance), Chittodvega (anxiety), Bhaya (fear), Harsha (exhilaration) etc. are due to specific conditioning of Mana.

In present era, everyone is trying to gain good education, a better financial status and to fulfil all the materialistic desires. Therefore, today’s society is facing unsteady, weakened, hard and everyday changing life style. As a consequence of this life style, almost everyone appears to be stressed and confused, this reflection can lead to mental disability like Chittodvega i.e., Generalised anxiety disorders. Anxiety is a universal experience, which has an important protective function in the face of danger.

Among the different types of Kumbhaka, Bhramari Kumbhaka is stated the best to give a blissful condition of mind. It is one of the best breathing practices to free the mind of agitation, frustration or anxiety and get rid of anger to a great extent. Therefore, it can be assumed that it can have a potential positive effect to reduce the symptoms of Chittodvega (GAD).

                                  

Significance

In present era, anxiety disorders are one of the most prevalent psychiatric disorders. In primary care, anxiety problems constitute around 22% of the cases noted. Individuals with anxiety are at significantly increased risk of impaired physical, mental and social health. COVID-19 pandemic triggers 25% increase in prevalence of anxiety and depression worldwide. Day by day, cases of anxiety and depression are increasing and in recent years several allopathic drugs, cognitive therapy, supportive psychotherapy and other therapies are used to manage the anxiety disorders. While discussing about the medicines and treatment facility regarding mental illnesses, there are almost no prescriptions without side-effects. Medicines used in such conditions may be addictive too. Because of this addiction, retrieval symptoms can also be observed at the end of drug therapies. Therefore, it is required that some drugless treatment approaches having very less or no side effects, cost effective, non-addictive, etc. in nature can be sorted to help the suffering humanity.

Aim and Objectives:

To evaluate the efficacy of Bhramari Kumbhaka in the management of Chittodvega (GAD) and also to assess the quality of life.

 

Materials and Methods:

  • 30 Patients with Chittodvega (GAD) will be enrolled. Bhramari Kumbhaka will be conducted in 7 cycles for 1st 15 days, 14 cycles for 2nd 15 days and 21 cycles for the next 15 days.

 

Results and Discussion:

Data generated during the above study will be present in a Systemic manner as shall be analyzed statically. Where the important points of the Conceptual study, Analytical study will be discussed.

Follow up:

After completion of therapy, follow up will be done for 4 weeks to assess the status of patient, where patient will be asked to report.

                                   

 

 

 


 

 

 

 

 
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