CTRI

Asthma, also known as struggling for breath, is a common lung disease in children, synonymous with bronchial asthma. Bronchial asthma is a non-communicable chronic inflammatory disease based on an inappropriate stimulation of the immune system. It is the most common allergic disorder in the childhood and leading cause of hospitalization. According to the global strategy for asthma management and prevention guidelines, asthma is characterized by increased airway hyperresponsiveness, coughing, chest tightness, prolonged expiration with wheezing, insomnia and recurrent episodes of dyspnea, especially at night or in the early morning.When lying down on the bed, discomfort increases, but sitting position provides comfort. This happens frequently in response to a stimulant in the environment (such as allergies), cold air, exercise, or emotional stress. Geographical location, environmental factors, racial traits, behavioral and lifestyle factors are some of the factors that contribute to childhood bronchial asthma.

The pathophysiology of asthma is complex, involving airway inflammation, airway obstruction (due to muscle spasm associated with mucosal edema and accumulation of the mucus), airway hyperactivity (due to aerobiologicals and irritants), and airway remodeling in uncontrolled asthma^. The interaction of genetics and environment, triggers many inflammatory cells which release a wide range of mediators.

Children with asthma are more prone to complications such as growth delay and delay in puberty, higher risk for learning disabilities, severe sleep deprivation. This leads to lack of physical ability, poor performance in school and sports, depression and weight gain. Patient who are untreated suffers from serious complication such as status asthmaticus, airway remodelling, bronchiectasis, allergic bronchopulmonary aspergillosis, fibrosis and finally respiratory failure and cor pulmonale.

The word Shwasa is derived from the root ‘Shwasa Prinane’– which actually means difficulty in the entry of prana in the Pranavaha Srotas. Shwasa word indicates both physiological and pathological state of respiration. Ayurveda described five types of Shwasa Roga (pathological conditions concerned with difficulty in breathing and associated clinical conditions). These include Urdhva Shwasa, Maha Shwasa, Chihnna Shwasa, Tamaka Shwasa, Shudra Shwasa^. On the basis of similarities in the sign, symptoms and etiopathogenesis bronchial asthma can be correlated with Tamaka Shwasa.

Tamaka Shwasa is a Swantarta vyadhi, having its own etiology, pathophysiology, and management. It is mentioned as Yapya Vyadhi, that is, a disease of the chronic nature and difficult to cure. Tamaka Shwasa is basically a disorder of Pranavaha Srotas while other Srotas are also vitiated.

Whether the ayurveda treatment protocol [AY/KB/NIA/TS-01/2024] is effective in pediatric bronchial asthma w.s.r. to tamaka shwasa ?

Null Hypothesis (H0) The ayurveda treatment protocol [AY/KB/NIA/TS-01/2024] is not effective in pediatric bronchial asthma w.s.r. to tamaka shwasa.

Alternate Hypothesis (H1) The ayurveda treatment protocol [AY/KB/NIA/TS-01/2024] is effective in pediatric bronchial asthma w.s.r. to tamaka shwasa.

To evaluate the efficacy of the ayurveda treatment protocol [AY/KB/NIA/TS-01/2024] in pediatric bronchial asthma w.s.r. to tamaka shwasa.

STUDY DESIGN

Study Type Open Label Interventional.

No of Groups One

SITE OF STUDY National Institute of Ayurveda, deemed to be University, Jaipur, Rajasthan.

STUDY SETTING Subjects will be selected from O.P.D & I.P.D of Department of Kaumarbhritya Balroga , NIA Jaipur

AGE GROUP 8-15 Years

Treatment protocol

S.N.	Procedure	Drug	Duration
1.	Steam Inhalation	Tailaparna Taila	5 drops in 20 ml hot water (5-7 min in morning & evening with empty stomach)
2.	Pratimarsha Nasya	Anu Taila	2-2 drops in each nostrils (In morning & evening just after steam inhalation)
3.	Oral medications	1. Devdarvyadi Syrup 2. Draksha-haritakyadi Avaleha	60 days (In morning & evening as per dose protocol)
4.	Breathing exercise	Anulom-Vilom Pranayama	10 minutes in morning and evening.

S.N.	Symptom	_G0	_G1	_G2	_G3
1.	Kasah (Cough)	Absent	After Exercise/ Exertion	Continuous, disturb work	Continuous, In resting position
2.	Ghurghuraka (Wheeze)	Absent	Moderate-often at the end of expiration	Loud throughout the expiration	Usually loud throughout Inspiration and expiration
3.	Shwasakrichhta (Dyspnoea)	Absent	Mild, Shwasakrichhta occurs on exertion	Shwasakrichhta occurs, after walking of 100 mt distance	Occurs, at rest
4.	Ativativra Vega Shwasa (Frequency of dyspnoea)	Absent	1-2 attacks/week and No Symptom between 2 attack	1 attack/ day, attack affects the activity	>1 attack/day, attack affects the activity
5.	Anidraa (Insomnia)	Never (sleep not disturbed)	Awake 1-2 time in night due to bout of asthma	Awake more than 3-4 times in night due to bout of asthma	Unable to sleep in night due to bout of asthma

Laboratory investigation Blood investigations CBC (Hb ,TLC , DLC,TEC)

Pulmonary function Peak Expiratory Flow Rate (PEFR)

RESEARCH OUTCOME

Primary Outcome Change in pulmonary functions in spirometry findings (peak expiratory flow rate).

Secondary Outcome To reduce the frequency and severity of asthmatic episodes.

Endpoint Efficacy of trial drugs

Treatment protocol

S.N.

Procedure

Drug

Duration

1.

Steam Inhalation

Tailaparna Taila

5 drops in 20 ml hot water

(5-7 min in morning & evening with empty stomach)

2.

Pratimarsha Nasya

Anu Taila

2-2 drops in each nostrils

(In morning & evening just after steam inhalation)

3.

Oral medications

1. Devdarvyadi Syrup

2. Draksha-haritakyadi Avaleha

60 days (In morning & evening as per dose protocol)

4.

Breathing exercise

Anulom-Vilom Pranayama

10 minutes in morning and evening.

Diagnostic Criteria

Pre diagnosed Subjects of Bronchial asthma (Tamaka Shwasa) or subjects those having clinical features of Bronchial asthma (Tamaka Shwasa).

ASSESSMENT CRITERIA

Clinical Assessment Subjective parameters with clinical feature assessment by scoring/grading system.

Symptom