| 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 |
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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 |
|
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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 |
|
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Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 , |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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: â—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.
â—The session will be conducted twice daily.
â—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.
â—The method to perform Bhramari Kumbhaka will)
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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.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
â—Bhramari Kumbhaka will be effective in the management of Chittodvega (GAD).
â—Reduction in sign and symptoms of Chittodvega.
|
45 Days
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| â— Improvement in the Quality of Life. |
45 Days |
|
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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
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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. |