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CTRI Number  CTRI/2023/06/054395 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 23/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   TO EVALUATE THE EFFECTIVENESS OF BHRAMARI PRANAYAMA IN CHITTODVEGA (GENERALIZED ANXIETY DISORDER).  
Scientific Title of Study   To Evaluate the Efficacy of Bhramari Pranayama in the Management of Chittodvega w.s.r. Generalized 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  Ashish kumar sharma 
Designation  PG Scholar 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved college Raipur 
Address  Department of Swasthvritta and yoga Shri Narayan Prasad Awasthi Govt Ayurved college Raipur
OPD Room No.6 Department of Swasthvritta and yoga Shri Narayan Prasad Awasthi Govt Ayurved college Hospital Raipur 492010
Raipur
CHHATTISGARH
492010
India 
Phone  8358898145  
Fax    
Email  ashish4117877@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita Sharma 
Designation  Professor Department of Swasthvritta and yoga 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved college Raipur 
Address  Shri Narayan Prasad Awasthi Govt Ayurved college Raipur
OPD Room No.6 Department of Swasthvritta and yoga Shri Narayan Prasad Awasthi Govt Ayurved college Hospital Raipur 492010
Raipur
CHHATTISGARH
492010
India 
Phone  9827115211  
Fax    
Email  ansharma260@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sasmita Tripathy 
Designation  Reader Department of Swasthvritta and yoga 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved college Raipur 
Address  Shri Narayan Prasad Awasthi Govt Ayurved college Raipur
OPD Room No.6 Department of Swasthvritta and yoga Shri Narayan Prasad Awasthi Govt Ayurved college Hospital Raipur 492010
Raipur
CHHATTISGARH
492010
India 
Phone  8763650383  
Fax    
Email  sasmita1980@gmail.com  
 
Source of Monetary or Material Support  
Department of Swasthvritta and yoga Shri Narayan Prasad Awasthi Govt Ayurved college Raipur  
 
Primary Sponsor  
Name  Dept of Swasthvritta and yoga Shri Narayan Prasad Awasthi Govt Ayurved college Hospital Raipur 
Address  Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chhattisgarh 
Type of Sponsor  Other [Government Ayurved College Raipur Chhattisgarh] 
 
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 Ashish kumar Sharma  Shri Narayan Prasad Awasthi Govt Ayurved college & Hospital Raipur   OPD No 6 Department of Swasthvritta and yoga
Raipur
CHHATTISGARH 
8358898145

ashish4117877@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Govt Ayurved college Raipur 492010  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: BhramariPranayama-Sit with erect spine in Padmasana or sukhasana & Sanmukhi Mudra,inhalation and exhalation with a hummingsound.Duration of pranayama in daily routine 10-15 times morning, evening & be, Ritucarya: None, Acara Rasayana:None, Other:None, Pathya/Apathya:yes, Pathya:Laghu aahar, Soyabeen, Milk, Almond, Seasonal fruits with Balanced diet in daily meal., Apathya:Guru Aahar, Refine oil, Junk foods( Pasta, Chaumin, Bread etc.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age between 18 to 60 years. 2. Presence of cardinal features of Chittodvega- Anxious mood, tension, fear, insomnia, intellectual, depressed mood, somatic muscular, somatic sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, Behavior at interview based on Hamilton anxiety scale HAM-A. 3.patient fulfilling the diagnostic and statistical manual of mental disorder fifth edition DSM-5. 4.cooperate and willing to participate in this study. 5.available at the time of data collection.  
 
ExclusionCriteria 
Details  1.Age below 18 years and above 60 years 2.Exhibiting psychotic symptoms. 3.factors interfering with concentration and communication 4.Hypertension 5.Diabetes 6.Ear disease 7.Any other systemic disease.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Presence of cardinal features of Chittodvega- Anxious mood, Tension, Fear, Insomnia, Difficulty in concentration, Depressed mood, Tachycardia, Palpitations, Constriction in chest, Looseness of bowels, Dry mouth, Restlessness  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Presence of cardinal features of Chittodvega- Anxious mood, Tension, Fear, Insomnia, Difficulty in concentration, Depressed mood, Tachycardia, Palpitations, Constriction in chest, Looseness of bowels, Dry mouth, Restlessness will be reduce.   45 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 1/ Phase 2 
Date of First Enrollment (India)   02/07/2023 
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="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  

Chittodvega is one of the Manasika Vikara mentioned in Ayurveda. The symptoms of this disease can be assumed mostly similar with Generalized anxiety disorder (GAD). Chittodvega can be defined as anxious status of mind. When abnormality of manas dosha continues for some time, It may develop psychic symptoms.  In the Charaka samhita vimana sthana Acharya Charak mentioned about two manas dosha Raja and Tama with its disorder Kama, Krodha, Lobha, Moha, Irsya, Maan, Mad, Shoka, Chittodvega, Bhaya, Harsha .The ancient science of yoga emphasizes "Chittavrittininodha" to calm the oscillation of the mind towards stability yoga therapy keeps the mind healthy and strong also reduces stress and promote relaxation.

The eight classical pranayama are very briefly and generally described in the Gheranda samhita and Hath yoga pradipika. Bhramari Panayama also known as humming Bee breath is a calming breathing practice that soothes the nervous system. The Bhramari Pramayama breathing technique derives its name from the black Indian bee called Bhramar, Bhramari pranayama is effective in instantly calming down the mind, it is one of the best breathing exercises to free the mind of agitation frustration or anxiety. In Hathyoga pradipika Yogi Svatmarama described Bhramari pranayama –

Breathing in rapidly with a resonance resembling the sound of a bee, exhale slowly, making, the humming sound of a female bee by the yoga which consists in practicing thus, there arises an indescribable bliss in the hearts of the best amongst the yogins. GAD is a disorder requires the presence of unrealistic or excessive anxiety and worry.  The anxious mood must continue for at least a month. The one year prevalence of generalized anxiety disorder in the general population is about 2.5-8%. It is the commonest psychiatric disorder in the population. In todays era people have anxiety disorders are one of the most common mental health problem. According to W.H.O. Covid 19 pandemic triggers 25% increase in prevalence of anxiety and depression worldwide and told that this is the wake up call to all the countries to setup mental health services and support. According to statistics on average 14 percent of Indians suffer from variations of mental health disorders in the country.

            So many researches shows that our physical health is related with our mental health. so mental health is just as important as physical health.The anxiety considered as Chittodvega in ayurveda text. There are many studies on the effect of Bhramari Pranayama on various systems, but there are only a few studies present on stress, anxiety depression and other mental disorders. Bhramari Pranayama is a yogic breathing practice which relieves anxiety, it is safe, easily to do, inexpensive and without side effects. Covid 19 pandemic is turning out to be a major stressor for most of humanity

 
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