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CTRI Number  CTRI/2024/07/071660 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 05/09/2025
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   EFFECT OF PRANAYAMA AND POSTURAL DRAINAGE ON OXYGEN SATURATION AND PULMONARY FUNCTION AMONG THE BRONCHIAL ASTHMA PATIENTS. 
Scientific Title of Study   SHORT TERM EFFECT OF PRANAYAMA AND POSTURAL DRAINAGE ON OXYGEN SATURATION AND PULMONARY FUNCTION IN BRONCHIAL ASTHMA PATIENTS 
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 Shilpa N M 
Designation  MD clinical yoga scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy & Yogic Sciences 
Address  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire belthangadi 574240 Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9632774932  
Fax    
Email  shilpamuniraju1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa N M 
Designation  MD clinical yoga scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy & Yogic Sciences 
Address  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire belthangadi 574240 Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9632774932  
Fax    
Email  shilpamuniraju1998@gmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Ganesh prasad 
Designation  Assistant professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy & Yogic Sciences 
Address  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,Department of research Ujire belthangadi 574240 Karnataka
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire belthangadi 574240 Karnataka
Dakshina Kannada
KARNATAKA
574240
India 
Phone  9632608127  
Fax    
Email  gpbnys@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Allopathy Hospital, Ujire, Karnataka 574240 
 
Primary Sponsor  
Name  Dr Shilpa N M 
Address  Sri Dharmasthala Manjunatheshwara College of Naturopathy & Yogic Sciences, Ujire- 574240 , Karnataka  
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 Shilpa N M  SDM multi-speciality hospital  SDM Multi-speciality hospital Ujire- 574240 (D.K), Karnataka
Dakshina Kannada
KARNATAKA 		 9632774932

shilpamuniraju1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala manjunatheshwara college of naturopathy and yogic sciences institutional ethical committee  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  postural drainage  participants will take part in a 20 mins of postural drainage session. 
Comparator Agent  Pranayama  participants will take part in a 20 mins session of pranayama for one week ,it includes a Dirga Svasam: (3-part, deep breathing or diaphragmatic breathing),Bhastrika pranayama,Suryabheda,Nadi shodhana ,Sasankasana breathing  
Intervention  pranayama and postural drainage  Participants will undergo both interventions for 50 mins, 20 mins of postural drainage followed by 10 mins of rest then 20mins of pranayama. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. EFA - Intervention in people with asthma and reported at least one of the following outcomes: asthma symptom score, lung function measures, asthma medication usage, and adverse events.
2. Age between 30 to 60 years.
3. 2‐6 exacerbations in the previous 12 months.
4. ACQ‐6 score ≥ 1.5 at least twice during screening.
5. Pre‐bronchodilator FEV1 90% and above.
6. People with asthma of any duration , severity, gender and ethnicity
 
 
ExclusionCriteria 
Details  1. Evidence of comorbidities like HIV/AIDS.
2. Presence of psychiatric co-morbidity
3. Other neurological diseases.
4. Known cases of uncontrolled hypertension.
5. Uncontrolled or unprotected airway with risk of aspiration.
6. Any cardiac disorders.
7. Valvular diseases and respiratory disorders like Bronchiectasis, Cystic fibrosis, and Pneumothorax.
8. Recent surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Oxygen saturation
2. Pulmonary function tests
 		 pre ,post 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/10/2024 
Date of Study Completion (India) 15/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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   Asthma is a chronic inflammatory condition of the airways that affects both the small and large airways. It involves various cells and cellular components such as mast cells, eosinophils, T lymphocytes, phagocytes, neutrophils, and epithelial cells. The condition is characterized by an increase in the airway reflex and a persistent inflammatory process, which leads to wheezing, coughing, chest tightness, shortness of breath, and respiratory failure, especially at night or in the early morning.Lung airways are impacted by chronic illness. The airways are the passageways that enable air to flow into and out of the lungs, allowing for the process of respiration. Swelling and increased mucus (inflammation) in the airways and constricted muscles surrounding the airways are the two main issues with asthma (bronchospasm). All ages’ respiratory and pulmonary physiology depend on airway shape and function. The initial embryonic creation and differentiation of cell types in conducting airways, as well as their function or malfunction throughout life, are in fact influenced by a range of normal and pathological processes.Pranayama is a scientific technique because it is a component of the "yoga" that Maharshi Patanjali codified In relation to yoga,  Only "asana" (postures) won’t help to improve chronic conditions; pranayama, a technique of breath regulation, must also be done in addition to the asana. Even young children, persons with medical conditions, and the elderly can practise pranayama without suffering any negative effects. Chest physical therapy (CPT) is a frequent approach utilised in the management of airway issues . Enhancing mucus clearance, lowering the risk of lung infection, and stopping pulmonary function decline are the main goals. Conventional CPT is utilised in some critically ill patients as well as stable COPD patients to prevent issues during the perioperative phase.There is very little evidence which proves that postural drainage and pranayama together have hand in hand effect on pulmonary function, so the current study focuses on assessing the efficacy of the lungs ability to ventilate by using all of their capacity, peripheral capillary oxygen saturation (SpO2%) and preventing exhaustion on practice of pranayama and postural drainage. Hence, Complementary and alternative medicine, such as yoga and chest physiotherapy can be explored as supportive therapies for bronchial asthma. 

  
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