Background and Objective. Tamalakyadi decoction (TD) is a classical formulation mentioned in authentic traditional medicine text Sarasankshepaya under nasal diseases and used as a remedy for allergic rhinitis. It consists of 12 plant ingredients. Decoction preparations are widely used in Sri Lankan traditional system and considered effective and safe for treating many disorders. However, decoctions have to be used only in fresh state due to shorter shelf life and loss of stability. This decoction preparation method leads to decreasing the patient compliance and is also time consuming. Hence, the objective of the present study was to convert TD to consumer friendly novel dosage form, namely, freeze dried, spray dried, and traditional ganasara forms. Methodology. Therefore, we compared the phytochemical constituents and antioxidant activities of TD with its modified dosage forms. The chemical comparison of four dosage forms comprises phytochemical screening, TLC and HPTLC fingerprint profiles and the antioxidant activities by DPPH free radical scavenging activity, Ferric reducing antioxidant power (FRAP), total polyphenol content (TPC), and total flavonoid content (TFC). Results. Phytochemical screening revealed the presence of alkaloids, saponins, tannins, steroids, flavonoids, phenols, and terpenoids in all dosage forms. However, the saponins, alkaloids, flavonoids, terpenoids, and steroids were more prominent in TD and freeze dried preparation than the other two preparations. HPTLC fingerprint pattern of freeze dried dosage was more similar with HPTLC fingerprint pattern of TD in terms of number of peaks and their intensity compared to that of spray dried and ganasara dosage forms. Antioxidant activities such as DPPH, FRAP, TPC, and TFC were higher in decoction and freeze dried preparation than in spray dried and ganasara preparation. Conclusion. Freeze dried TD is the most suitable ready to use preparation having similar chemical properties and antioxidant activities to TD.

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.

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