Immediate effect of Vamana Dhauti and Cold Chest pack on pulmonary function among bronchial asthma patients- A Randomized three-arm study

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.