1. Safety and Efficacy of Ayurveda compound formulations (Kantakaryavaleha and Eladi Gutika) in the management of Mild Stable Bronchial Asthma (Tamaka Shwasa): Result from a prospective, open-label, multicenter, single-arm feasibility clinical trial
- Author
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Harbans Singh, G Babu, BS Sharma, Shruti Khanduri, Anjali Prasad, K Anumol, Bidhan Mahajon, BCS Rao, Rakesh Rana, Arunabh Tripathi, and Narayanam Srika
- Abstract
Background Bronchial asthma (BA) is a significant health problem and harms the quality of life, and better healthcare strategies are still needed for BA. Therefore, the scope of complementary and traditional medicine therapies on this concern must be explored. Thus the present study aimed to determine the efficacy and the safety of Kantakaryavaleha and Eladi Gutika in mild, stable bronchial asthma Method This prospective, open-label, multicenter clinical feasibility trial executed at two different OPD under Central Council for Research in Ayurvedic Sciences (CCRAS). In this study, 83 diagnosed cases of mild stable BA, 18–60 years age, were evaluated to assess the efficacy and safety of Kantakaryavaleha and Eladi Gutika. Eladi Gutika 1 gm thrice daily and Kantakaryavaleha 20 ml twice daily with an equal quantity of water were administered for 84 days. Primary outcome measures were done by changes in Asthma Control Questionnaire (ACQ) scores and frequency of need for control medication. The secondary outcome measures were assessed by changes in FEV1, serum CRP, serum IgE, frequency of need for rescue medication, and any adverse events. Results Significant (p viz. paroxysm of breathlessness, wheezing, cough, expectoration of sputum, tightness in the chest, skin allergy, worsening of breathlessness at night, awakening in the night. In Asthma Control Questionnaire (ACQ) score and FEV1 parameters also, significant (p Kantakaryavaleha and Eladi Gutika are effective and safe in managing mild, stable bronchial asthma. A multicentric, double-blind, randomized controlled trial (RCT) may be planned with a more extended follow-up period to aid in the present findings. Trial registration: The clinical trial has been registered in the Clinical Trial Registry of India (CTRI/2018/06/014425) /http://ctri.nic.in.
- Published
- 2022
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