An Open Single Arm Single Centric Phase-II Clinical Trial to evaluate the effectiveness of Thoothuvalai Nei in the treatment of Eraippu Noi (Childhood Bronchial Asthma) in Children

INTRODUCTION: This is an Open Single Arm Single Centric Phase II Clinical Trial to Evaluate the Effectiveness of Thoothuvalai Nei in the Treatment of Eraippu Noi (Childhood Bronchial Asthma) in Children. Eraippu Noi is otherwise called Ezhuppu Noi or Swasakasam. Eraippu Noi is characterized by the tightness of the chest, difficulty in breathing in which expiratory breathing sound resembles the sounds of musical instruments like flute, loot or veena, presence of cold with or without expectoration during cough according to the Pediatric Siddha textbook Pillaippini Maruthuvam. MATERIALS AND METHODS: In an Open Single Arm Single Centric Phase II Clinical Trial, children within the age limit of 5-12 years will be enrolled based on inclusion and exclusion criteria after signing the consent form by the parent /Guardian and assent form by the children.  After enrolment, the trial drug Thoothuvalai Nei (Dosage : 5 ml for  5 - 7 years, 8 ml for 8 – 12 years) will be given once a day in the morning after food for 45 days. DATA ANALYSIS: The data will be analyzed using the statistical analysis method. OUTCOME: The outcome will be assessed using Peak Expiratory Flow Meter and PASS Score.