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 practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety
of a decoction used in traditional Ayurveda for allergic rhinitis and its ready- to-use freeze dried formulation in
comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis.
Study design: This is a three-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling patients
with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freezedried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested
against the antihistamine loratadine. Patients with symptoms of AR will be allocated randomly into the three arms
after a 1-week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS)
of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the
three arms prior to visit 1, at the end of 28 days, and end of the first and second months 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 evidence-based scientific data on Ayurvedic dosage form,
TMD12, and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop
capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of
various disease conditions.
