Article: A PHASE III, OPEN-LABEL, TWO-ARM, MULTI-CENTER, COMPARATIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AMASTHA AWALEHA IN SUBJECTS WITH BRONCHIAL ASTHMA

Article Category: Original Research articles

DOI: 10.7897/2277-4343.17250

Pages: 48-58

Author: Tarun Maheswari, Nikhil Maheshwari *

Abstract: Background: Bronchial asthma is a chronic inflammatory airway disorder associated with recurrent respiratory symptoms. In Ayurveda, bronchial asthma is correlated with Tamaka Shwasa, predominantly involving Vata and Kapha dosha imbalance. Objective: To evaluate the safety and efficacy of Amastha Awaleha as an adjunct to Standard of Care (SOC) in bronchial asthma. Materials and Methods: In this prospective, two-arm, open-label, multi-centre study, conducted at two centers. 100 participants (18–60 years) with bronchial asthma were randomized into two groups; 98 completed the study. The intervention group received Amastha Awaleha (1–2 teaspoons twice daily) along with SOC after food, while the control group received SOC alone after food for 90 days. Outcomes included assessment of spirometry parameters (FEV₁, FVC), symptom severity, rescue inhaler use, Asthma Control Questionnaire (ACQ) scores, and quality of life (SF-36). Safety was assessed through monitoring the adverse events, laboratory parameters and vital signs. Results: Both groups showed significant improvement; however, greater changes were observed in the intervention group. FEV₁ improved from 1.96 L to 3.73 L and FVC from 2.60 L to 3.68 L, compared to FEV₁ from 2.22 L to 3.35 L and FVC from 2.80 L to 3.37 L in the control group. Rescue inhaler use reduced more markedly in the intervention group (2.6 to 0.7 vs 2.87 to 1.32). ACQ scores improved significantly, with greater reduction in the intervention arm. Substantial enhancements were noted across multiple SF-36 quality of life domains. No serious adverse events were reported, and compliance was high (98%). Conclusion: Amastha Awaleha as an adjunct to SOC significantly improved lung function with reduction in symptom severity and rescue inhaler use, and enhanced quality of life, with a favorable safety profile and tolerability.

Keyword: Amastha Awaleha, Bronchial Asthma, Asthma Control Questionnaire (ACQ), SF-36, Rescue Inhaler Use, Lung Function.