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CTRI Number  CTRI/2024/04/065361 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Vamana Dhauti On Bronchial Asthma Patients  
Scientific Title of Study   Effect of Vamana Dhauti on Pulmonary Function Test among Bronchial Asthma patients A Randomized Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kallol Pandey 
Designation  Post Graduate Stuent  
Affiliation  Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences 
Address  Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass road, Meerut 250005, Uttar Pradesh, India

Meerut
UTTAR PRADESH
250005
India 
Phone  8009620894  
Fax    
Email  kallolpandey4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nair Dhiren Ajit 
Designation  Assisstant Professor 
Affiliation  Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences 
Address  Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass road, Meerut, Uttar Pradesh, India

Meerut
UTTAR PRADESH
250005
India 
Phone  7899143619  
Fax    
Email  danny.a.nair@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay M Shankar Gowda  
Designation  Principal and Dean 
Affiliation  Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences 
Address  Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass road, Meerut, Uttar Pradesh, India

Meerut
UTTAR PRADESH
250005
India 
Phone  9448300347  
Fax    
Email  naturopathy@subharti.org  
 
Source of Monetary or Material Support  
Subjects will be recruited from Maharishi aurobindo subharti college & hospital of naturopathy & yogic sciences (IPD&OPD) , chhatrapati shivaji subharti hospital and subharti university  
 
Primary Sponsor  
Name  Dr Kallol Pandey 
Address  Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass road, Meerut 250005, Uttar Pradesh, India 
Type of Sponsor  Other [SELF] 
 
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 KALLOL PANDEY  Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences  Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass road, Meerut 250005, Uttar Pradesh, India
Meerut
UTTAR PRADESH 		 8009620894

kallolpandey4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee Medical  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J452||Mild intermittent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DIAPHRAGMATIC BREATHING  Diaphragmatic Breathing Procedure: - Lie down in a supine posture with one hand on the abdomen and the other on the chest, and breathe in slowly and deeply through the nose while using the diaphragm and moving the chest as little as possible. While breathing, practitioners should maintain their stomach moving against their hand, focused on clenching their diaphragm and keeping their chest as calm as possible. Diaphragmatic Breathing practitioners typically inhale and expel for roughly six seconds. Time: 15-minute diaphragmatic breathing session 
Intervention  VAMANA DHAUTI  First, the subject is asked to sit in a squatting position. Then the subject is asked to drink warm saline water non-stop until their stomach is full and they can hold no more water, at this point, they have to drink another glass of water. Although a little challenging, it is imperative to try to fill the stomach to the brim. In these conditions, the desire is hardly necessary to excite the stomach to expel the water. It might happen on its own. Six glasses of 300ml is the average amount of water needed to fill the stomach. Then Bend forward from a standing position to any container design to collect vomitus. The trunk is horizontal as possible, then open your mouth as wide as possible. This should cause the water to flow smoothly and abruptly from the stomach, gushed out. Keep going in this manner up until the stomach is empty of water. This is seen when nothing more comes up when you tickle the back of the throat. It now completes the process of Vamana dhauti. Time: The ideal time to practice Vamana dhauti is early in the morning before breakfast. The subjects are asked to do vaman dhauti 2 times a week for 4 weeks.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Based on clinical signs and symptoms. The study includes bronchial asthma with a history not less than one
year. Those who are willing to participate. The study includes only those patients who fulfilled the diagnostic
criteria  
 
ExclusionCriteria 
Details  Patients suffering from Pulmonary tuberculosis, Carcinoma of the lung,Pregnancy, Lung fibrosis
Bronchiectasis
Cor pulmonale
Ischemic heart disease and any additional systemic illness were
excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PULOMONARY FUNCTION TEST  PRE AND POST TREATMENT 
 
Secondary Outcome  
Outcome  TimePoints 
QUALITY OF LIFE QUESTIONNAIRE  PRE AND POST TREATMENT 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "148"
Final Enrollment numbers achieved (India)="148" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/04/2024 
Date of Study Completion (India) 16/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Bronchial asthma is a chronic disease of airways, identified by bronchial
hyper-reactivity and varying degrees of airway blockage  with the
associated symptoms of chest tightness, wheezing, coughing, and dyspnea.The prevalence of self-reported asthma in India was 1.8% (95% CI 1.6-2.0) in men and 1.9% (95% CI 1.8-2.0) in women, with rates higher in rural than in urban areas and significant geographic differences . There are presently over 300 million asthma cases present globally, or about a quarter of the worlds population and about 10th of those living in India.Asthma risk factors include gene-by-environment interactions.
Environmental factors, such as infections and endotoxin exposure, can act as protective or risk factors in children and adolescents, depending on when they are exposed. There are some well-established prenatal risk factors, such as maternal smoking, but others, such as diet and nutrition, stress, the use of antibiotics, and delivery methods, may also have an impact on the early onset of allergy and asthma.The following four mechanisms are the primary causes of
airway blockage in bronchial asthma-
(1) Bronchial smooth muscle contraction
(2) Edema of the airway walls,
(3) bronchial tube obstruction by mucus, and
(4) Irreversible changes to the lungs (remodeling)
Nowadays patients are being prescribed higher doses of Inhaled
corticosteroids for a longer duration this leads to oropharyngeal candidiasis and dysphonia are major side effects of ICS treatments and other dose- dependent systemic effects are suppression of the hypothalamic-pituitary- adrenal axis, bone loss, skin thinning, increased cataract development, glaucoma, metabolic changes, and behavioral abnormalities.It is considered that the use of complementary and alternative medicine (CAM) has minimum side effects as compared to any other system of medicine and it is also cost-effective.Patients having
asthma use complementary and alternative medicines (CAMs) to improve
their asthma symptoms.According to Hath yoga, yoga is a physical practice that helps to control asthma by connecting the body and mind through the breath and allowing them to function as a single unit.In yoga Six purification techniques are mentioned in the Hatha Yoga,
which is considered to balance a person constitution. These six yogic purification techniques referred to as shatkarma or shatkriya are claimed to promote health and well-being.The Shatkriya technique includes dhauti (internal cleansing), Basti (yogic enema), neti (cleaning of nasal passage), trataka (concentrated gazing), nauli (abdominal massaging) and kapalabhati (frontal sinus cleansing). The major goal of Shatkriya is to bring the body’s three tridoshas —(kapha) mucus, (pitta) bile, and (vata) wind —into harmony. Dhauti means & internal cleansing.Vamana is the shatkarma technique which involves 2-3 liters of warm saline water drinking slowly and trying to induce voluntary vomiting  . Warm water helps dissolve fat, lose weight, aid in digestion, and lessen excess Kapha Toxins are removed from cells by osmosis with the aid of salt water. It is a purifying procedure that enhances hunger, enhances appetite,
normalizes bowel movements, somewhat relieves the heaviness felt in the
stomach after eating and enhances sleep patterns.The regular practice of Vamana dhauti on healthy volunteers contributed to improved vagal tone and pulmonary functioning. These results were based on rise in forced inspiratory volume and slow vital capacity, in addition to decrease in expiratory reserve volume and respiratory rate.In a 2019 study conducted by V Singh on seven patients “Kunjal: A Nonspecific Protective Factor in Management of Bronchial Asthma. In this paper, he took only PEFR as a parameter and found that after kunjal kriya, the asthmatic parameters showed significant improvement both during the first week and the week after the maneuver. Till now no study has been done as a randomized controlled trial on the effect of Vaman dhauti in PFT parameters
among bronchial asthma patients.
 
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