A Prospective Open-Label Clinical Trial To Evaluate The Efficacy Of Ayurveda Treatment Protocol [AY/KB/NIA/TS-01/2024] In Pediatric Bronchial Asthma With Special Reference To Tamaka Shwasa

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.

RESEARCH QUESTION

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

HYPOTHESIS

Null Hypothesis (H****0)  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 (H****1) The ayurveda treatment protocol [AY/KB/NIA/TS-01/2024]  is effective in pediatric bronchial asthma w.s.r. to tamaka shwasa.

AIM

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.

OBJECTIVES

Primary Objective

To assess the change in spirometry findings.

Secondary Objective

To reduce the frequency and severity of asthmatic episodes.

To restore normal airway functions.

STUDY DESIGN

Study Type Open Label Interventional.

No of GroupsOne

SITE OF STUDYNational 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.ProcedureDrugDuration
1.Steam InhalationTailaparna Taila5 drops in 20 ml hot water(5-7 min in morning & evening with empty stomach)
2.Pratimarsha Nasya                 Anu Taila2-2 drops in each nostrils(In morning & evening just after steam inhalation)
3.Oral medications1. Devdarvyadi Syrup**2. Draksha-haritakyadi Avaleha                      60 days                                                (In morning & evening as per dose protocol)
4.Breathing exerciseAnulom-Vilom Pranayama10    minutes in morning and evening.

Duration of Study18 Months

Sampling MethodConvenienceSampling

Sample Size30

Diagnostic CriteriaPre diagnosed Subjects of Bronchial asthma (Tamaka Shwasa) or subjects those having clinical features of Bronchial asthma *(Tamaka Shwasa).*ASSESSMENT CRITERIAClinical AssessmentSubjective parameterswith clinical feature assessment by scoring/grading system.

S.N.

   SymptomG0

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 onexertion

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 investigationBlood investigations CBC (Hb ,TLC , DLC,TEC)

Pulmonary function Peak Expiratory Flow Rate (PEFR)

RESEARCH OUTCOME

Primary OutcomeChange 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

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