Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

Abstract

Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system in Sri Lanka. The aim of this study is to find out whether the use of two preparations (decoction and its freeze dried powder) over a period of 4 weeks is able to cure the symptoms of allergic rhinitis. Study design This is a three arm open label non-inferiority randomized controlled clinical trial in patients with AR. The study duration is 28 days oral administration of the two Ayurvedic dosage forms (Decoction and freeze dried) and the antihistamine loratidine into the 3 arms allocated randomly. After a 1 week run-in period, eligible subjects are randomly assigned to the TMD12 decoction group, TMD12 freeze dried group and the antihistamine group. Total Nasal symptom Score (TNSS) of the patients are used as the primary efficacy outcome. TNSS is recorded and compared in all 3 arms prior to visit 1, at the end of 28 days, end of the first month of follow up and second month of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion This clinical trial will be able to provide supportive evidence based scientific data on classical Ayurvedic dosage forms and the new dosage forms developed as freeze dried powder in the treatment of allergic rhinitis. Also by this trial, it is expected to develop capacity to scientifically evaluate Ayurvedic treatments that may help patients having conditions such as allergic rhinitis.