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CTRI Number  CTRI/2023/11/059807 [Registered on: 14/11/2023] Trial Registered Prospectively
Last Modified On: 13/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Immediate effect of Vamana Dhauti and Cold Chest pack on pulmonary function in bronchial asthma individuals 
Scientific Title of Study   Immediate effect of Vamana Dhauti and Cold Chest pack on pulmonary function among bronchial asthma patients- A Randomized three-arm study 
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 Hema Chaitanya Latha Reddy  
Designation  MD Scholar 
Affiliation  Rajiv Gandhi University of Health Sciences Bengaluru 
Address  DEPARTMENT OF YOGA,SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9502836523  
Fax    
Email  drhemamdyoga@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr GANESH PRASAD 
Designation  ASSOCIATE PROFFESOR 
Affiliation  Rajiv Gandhi University of Health Sciences Bengaluru 
Address  DEPARTMENT OF YOGA, SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9632608127  
Fax    
Email  gpbnys@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hema Chaitanya Latha Reddy  
Designation  MD Scholar 
Affiliation  Rajiv Gandhi University of Health Sciences Bengaluru 
Address  DEPARTMENT OF YOGA, SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9502836523  
Fax    
Email  drhemamdyoga@gmail.com  
 
Source of Monetary or Material Support  
Participants will be recruited from Sri Dharmasthala Manjunatheswara Yoga and Nature Cure Hospital (Shantivana), Ujire, Dharmastala. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Hema Chaitanya Latha  SDM Yoga & Nature Cure Hospital Shanthivana  DEPARTMENT OF YOGA, SDM Yoga & Nature Cure Hospital Shanthivana Dharmasthala [DK]- 574216
Dakshina Kannada
KARNATAKA 
9502836523

drhemamdyoga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM Institutional Ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cold Chest pack  The Procedure of the Cold Chest Pack involves after receiving the intervention, the participants will be requested to lie down on the massage table in the supine position with little clothing on. The patients will be instructed to sit before the intervention is administered. The participants must consume one glass of water before to the intervention. A cotton cloth of roughly 2.5 meters in length and 0.5 meters in breadth will be soaked in water between 12 to 18 degrees Celsius, completely wrung out, and then placed over the chest area, covering the front and back. The wet cloth is wrapped tightly in a wool blanket that is comparable in breadth but somewhat longer, making it fit more snugly at each place to keep out air, for 15 minutes.  
Intervention  Vamana Dhauti  The procedure of the Vamana Dhauti ritual includes sipping warm water with 1 liter of water and 1 teaspoon of salt added. Vamana dhauti is performed in the morning on an empty stomach while sitting in a squatting position till the person feels full or queasy. Beforehand, wash the hands and make sure the nails are well clipped. The person is then instructed to rise, lean forward from the lower back, and deliberately induce vomiting by lightly stroking the uvula and tongue root. It has been noted that with practice, triggering the vomit may only be necessary once or not at all, but in beginners, triggering may be necessary three to four times before the majority of the drank water is vomited up. The participants should rest supine and voluntarily relax the entire body for 10 minutes following vomiting. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  2‐6 exacerbations in the previous year
Patients with a history of asthma or other typical clinical symptoms associated with respiratory issues
ACQ‐6 score ≥ 1.5 at least twice during screening
Willingness to participate in the study
 
 
ExclusionCriteria 
Details  Weak and debilitating individuals
No indication of coexisting conditions like HIV/AIDS
Existence of co-morbid psychiatric conditions
With other severe primary diseases including cancer, bronchiectasis, cardiac insufficiency, and other conditions.
Cardiac disorders like Arrhythmias, Coronary artery disease, and Recent Myocardial Infarction.
Recent surgery
Pregnant women
Subjects with open wounds
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
pulmonary function test  15MINS PRE AND POST  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   27/11/2023 
Date of Study Completion (India) 31/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 respiratory disease characterized by the inflammation of airways that affects up to 18% of people worldwide. Airway hyperresponsiveness, a heightened airway response to specific stimuli such as viruses, allergens, and exercise, is associated with chronic inflammation. This results in recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, which can change over time and in intensity. All age groups are affected by the major worldwide health issue of asthma. In many countries, especially among youngsters, its frequency has grown. The Global Initiative for Asthma (GINA) offers doctors worldwide an up-to-date evidence-based approach, tools, and helpful resources with the goal of improving asthma diagnosis, treatment, and prevention. The main pathophysiological characteristics of Asthma are caused by inflammation and airway remodeling. This includes various changes such as goblet cell hyperplasia, subepithelial fibrosis, collagen deposition, mucosal gland hyperplasia, smooth muscle hypertrophy, and alterations in the extracellular matrix. Inhaled corticosteroids (ICS) are a primary treatment for controlling asthma. Patients should begin with a low dose, which can be increased based on the severity of symptoms. Non-pharmacological treatment of bronchial asthma involves making lifestyle modifications that can help alleviate bronchial conditions without medication. These modifications include adopting a balanced diet, quitting smoking, and avoiding a sedentary lifestyle. Physical training, respiratory therapy, breathing exercises, and psychosocial treatments can also be helpful in managing bronchial asthma. Hatha yoga is a practice that involves six purification techniques known as shatkarmas. Dhauti is one of the six cleansing techniques in yoga, also known as Shatkarmas or Shatkriyas. Its primary purpose is to cleanse the entire digestive tract, and it also impacts the respiratory tract, external ears, and eyes.  Smoking, mouth breathing, and a poor diet can cause toxic wastes to build up on the mucus linings of the lungs and trachea, which can prevent them from working correctly. Vamana dhauti on an empty stomach helps to remove surplus mucus and reduces tension by triggering a nerve reaction in the lungs. Every day, under the guidance of trained instructors, Vamana Dhauti is recommended for asthmatics. The cold chest pack is used because It relieves congestion of the lungs, decreases pulmonary mucus membrane irritation, and increases the depth of respiration, pulmonary tuberculosis, chronic bronchitis, chronic pneumonia, chronic pleuritis, pulmonary haemorrhage, and threatened cardiac failure. AIM: To evaluate the impact of the immediate effect of Vamana Dhauti and Cold Chest pack on pulmonary function in bronchial asthma patients.
 OBJECTIVES: To evaluate lung capacity and function.
To evaluate the impact of Vamana Dhauti and a Cold Chest pack
To decrease the frequency of acute exacerbations.

Source of Data: Participants will be recruited from Sri Dharmasthala Manjunatheswara Yoga and Nature Cure Hospital, Shantivana, Ujire, Dharmasthala.

Method of Data Collection: Criteria for diagnosis
Asthma Control Questionnaire (ACQ): The seven items that the researchers found as being essential for judging the effectiveness of asthma management are listed below. In order to complete the first six questions on a seven-point scale (0 being the least impairment and 6 being the most impairment), patients are asked to recall their events from the previous week. The six inquiries are about waking up throughout the night, waking up with symptoms, activity restriction, shortness of breath, wheezing, and usage of rescue short-acting 2-agonists. A comparable seven-point scale is used by clinic personnel when rating FEV1% expected before to bronchodilator. The ACQ score ranges from 0 (completely controlled) to 6 (severely uncontrolled), with each of the seven elements receiving equal weight. Both clinical and research settings can benefit from the ACQ’s outstanding measuring characteristics.
Design: A Randomized three-arm study
Sample Size: potential subjects will be screened, and eligible patients will be recruited for the study randomly. Three groups with 25 subjects in each will be taken for study. 
a) Randomization: The study is a three-arm, parallel-group, randomized trial. Following the inclusion and exclusion criteria, patients will be randomly allocated to one of the three treatment groups in a ratio of 1:1:1.
Using a computer-generated random number table, the research statistician will create the allocation sequence. The research investigator will choose the lowest numbered envelope and open it to disclose the participant’s assignment after receiving written informed consent and baseline measurements.
b)   Methodology: The subjects will be considered for the study after screening as per the demands of inclusion and exclusion criteria. Before participants complete a written informed consent form, they will receive comprehensive verbal information about the study. Recruitment of participants will be conducted prospectively. Selected participants will be allocated to one of the three groups. Group 1 participants will undergo Vamana dhauti. Group 2 participants will take a Cold chest pack for a duration of 15 minutes. Group 3 participants will undergo both interventions. Pre and post data will be collected before and after the intervention from each participant. The Data collected will be tabulated and analyzed using appropriate statistical methods.
ASSESSMENT: Subjects will be assessed for the Pulmonary Function test. The assessments will be carried out 5 min before the intervention and within 10 min after the intervention.
Pulmonary Function test: For determining lung function, spirometry is advised. A portable spirometer, the Contac SP 10, will be used to evaluate the measurements. monitoring lung function in a simple and affordable way. It is used to find out the following measures.
a) Forced vital capacity (FVC) will be expressed in liter
b)  Forced expiratory volume at 1 second (FEV1) will be expressed in liter
c)  Forced expiratory flow (FEF25-75%) and peak expiratory flow (PEF) will be expressed in liter/second.
During each measurement, the Maneuver will be performed three times, and the highest reading among the three valid readings will be used to determine the final result for that sitting.
Data Extraction: The data will be collected using a Contac SP 10 handled spirometer to assess respiratory variables.
Assessments will be conducted both before and after the intervention, and the data will be stored in numerical form on Microsoft Excel sheets.
SPSS (Statistical Package of Social Sciences) version 28 [Computer program] will be used to analyze the data.
There were individual studies conducted on the effect of Vamana dhauti and cold chest pack on bronchial asthma, since there are no specific studies conducted on this particular topic this study aims to assess the compared effects of Vamana dhauti and cold chest pack on Pulmonary function among bronchial asthma individuals. Hence this study is hypothesised to compare the effect of Vamana dhauti and cold chest pack on bronchial asthma individuals.

 

 
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