A Comparative Clinical Study to Evaluate the Efficacy of Agastya Haritaki Rasayana and Gudardraka in the Management of Kaphaja Kasa (Wet Cough) in Children: An Open-Label Randomized Controlled Study

In Ayurveda Kasa (Cough) is explained under Pranavaha Srotovikara. Kaphaja Kasa is a one type of Kasa Roga and is characterized by Snigdha (Unctuous), Ghana(Solid), Sandra Kaphasthivana (Cough with expectorant) other features associated with Peenasa (Nasal discharge), Chardi (Vomiting), Alparuk in Uras (Mild chest pain), Sthaimitya (Heaviness in the chest), Kanthaupalepa(Coating in the throat), Mandagni (Reduced appetite), Aruchi (Anorexia) and Sampoornavakshas (Fullness in the chest)etc. Children naturally having Kaphadosha predominant and indulging of Kaphakara Ahara and Vihara, produces more incident of KaphajaKasa. Global Challenge: Cough is one of the most common complaints prompting patient visits to health care professionals, especially in paediatric clinic. Cough is the 5th common complaint for which patients seek care and prevalence rate of which is 25% in children worldwide. Two thirds of children, visit their doctors at least once a year with acute respiratory infections, and up to three-quarters of them will have a cough which sounds wet. Allopathic Medication for Cough: Treatment for wet cough in allopathy mainly comprises of Antibiotics, Antitussive, and other symptomatic treatment. In the majority of cases of wet cough lesser than 14 days are caused by viral, upper respiratory tract infections which do not warrant specific treatment or lesser treatment. Owing to the similarity in the etiology and symptoms, the management of Kaphaja Kasa holds good for wet cough. Here Ayurveda may prove as harmless natural management in Kaphaja Kasa (wet cough) of chronicity lesser than 14 days. Ayurvedic Treatment Approach: Ayurveda proposes a comprehensive management guideline for Kasa that include drugs and formulations. Deepana, Strotoshodhana, Katu, Ruksha, Ushna, Kaphaghna treatment forms the basis principles of Kaphaja Kasa (wet cough).   Study Drugs: **AGASTYA HARITAKI RASAYANA :**Drug Reference  is from classical Ayurveda text Astangahridya, Chiktsasthana, Adhyaya 3:125-130 1/2) and API, part- 1,second edition, page 108. **GUDARDRAKA:**Drug Reference is from classical Ayurveda text Sahasrayoga, lehyaprakrana, page285. Both the formulations are in Avleha form with natural ingredients, which is palatable to children. Study Objectives: Primary: 1. To compare the efficacy of Gudardraka and AgastyaHaritaki Rasayana on the clinical features of Kaphaj Kasa in Children.  Secondary: 1. To study the efficacy of Gudardraka and Agastya Haritaki Rasayana in the improvement of quality of life. 2. To study the safety of Gudardraka and Agastya Haritaki Rasayana in the management of Kaphaj Kasa in Children. Primary outcome measures : a.       The primary outcome measure will change in the clinical symptoms grading of Kaphaj Kasa. Secondary outcome measures: a. Change in Leicester cough Questionnaire to evaluate the impact of cough on quality of life.  b. Change in values of laboratory parameters. CBC, KFT ,LFT to assesses safety of drug.  c. PEFR to assess ventilation adequacy  c. Assessment of the safety of the drug by documenting the occurrence of any adverse drug reactions (ADR)/adverse events (AE) during the course of the study. Significance: Offers a Ayurveda management childhood wet cough without harmful side effects.