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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Lifestyle | - | - | 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 |