Efficacy of Galphimia glauca in the Treatment of Allergic Rhinitis: A Double-Blind, Randomized, Placebo-Controlled Trial

Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and rhinorrhoea (nasal discharge) and is caused by immunoglobulin E (IgE)- mediated reactions to inhaled allergens. The disease currently affects between 10% and 30 % of the population. It was defined in 1929: The three cardinal symptoms in nasal reactions occurring in allergy are sneezing, nasal obstruction and mucous discharge. AR is a global health problem that causes major illness and disability worldwide. The ARIA guidelines for classification and treatment of allergic rhinitis have led to the definition of allergic nasal disease as intermittent or persistent and mild or moderate-to-severe. The diagnosis is based on the concordance between a typical history of allergic symptoms and diagnostic tests. Several trials have evaluated the effectiveness of homeopathy for AR. Results from these trials are mixed. Collectively, the results of these trials have been noted to be positive. No double- blind trial has been found in the Indian context. This trial aims to evaluate the efficacy of Galphimia glauca in the treatment of allergic rhinitis. By meta-analysis in the year of 1997, significant superiority of Galphimia glauca (GG) over placebo is demonstrated. The research gap is despite the promising findings reported in the 1997 meta-analysis demonstrating the significant superiority of Galphimia glauca (GG) over placebo in alleviating symptoms of pollinosis (allergic rhinitis), several critical limitations remain that hinder the generalizability and robustness of the conclusions like lack of Intention-to-Treat (ITT) Analysis,  unvalidated outcome measures, no replication and independent verification. So, by this double-blind, randomized (2:1), placebo controlled trial conducted at Jawaharlal Nehru Homoeopathic Medical College Hospital on 106 (Verum group- 71 and Control group 35) patients suffering from AR, it would be an attempt to overcome those limitations of previous studies and will act as future research evidence in homoeopathy for the treatment of AR as well as it will help for further systematic review and meta-analysis. Primary outcome measure will be Mini-RQLQ at baseline, every month up to 2 months of follow up. Secondary outcome measure will be (a) SF 12 at baseline, every month up to 2 months of follow up. (b) Serum IgE level and (c) Absolute Eosinophil Count (AEC) at baseline and end of 2 months of follow up. Group differences will be analyzed statistically. Results will be published in scientific journal.