Proof of Efficacy Study to Evaluate an Ayurvedic Formulation in the Treatment of Allergic Rhinitis: An Open Label Randomized Controlled Clinical Trial
Abstract
Background: Allergic rhinitis is largely treated by using antihistamines and nasal sprays, either alone or in combination. However, these measures ease out the symptoms but do not address causative factors, and have their share of side effects and limitations. An Ayurvedic herbo-mineral formulation, IMMBO, has been reported to be effective in treating allergic rhinitis. Objective: The present study was carried out to evaluate the efficacy, safety, and tolerability of the Ayurvedic herbo-mineral formulation in comparison with a fixed-dose combination of levocetirizine and montelukast. Method: This was a randomized, comparative, clinical study carried out on 250 patients at a medical college in India. The patients were enrolled according to the eligibility criteria of the study and randomized into two groups, to receive either Ayurvedic herbo-mineral formulation, IMMBO, or a combination of levocetirizine and montelukast for 28 days. Total nasal symptom score (TNSS) and Immunoglobulin E (IgE) were calculated for evaluation of efficacy parameters. Result: At the end of therapy both IMMBO and levocetirizine and montelukast combination showed significant improvement in TNSS in both treated population and per protocol population. The IMMBO group had a statistically higher reduction in TNSSs compared to the levocetirizine + montelukast group (-5.70 vs. -3.31; p<0.01). There was a statistically significant difference in the reduction of IgE levels between the groups (-351.54 vs.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 250 participants or records.
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