Preliminary Study on Safety and Efficacy of a Thai Herbal Remedy in Persistent Allergic Rhinitis: A Randomized Double-blind Placebo-controlled Trial
Tandhavadhana S, MSc1, Maek-A-Nantawat W, MD2, Phonrat B, MSc3, Picheansoonthon C, PhD4,
Affiliation : Pitisuttithum P, MD3
1 Faculty of Medicine, Mahasarakham University, Mahasarakham, Thailand
2 Center of Excellence for Biomedical and Public Health Informatics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
3 Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
4 College of Alternative Medicine, Chandrakasem Rajabhat University, Bangkok, Thailand
Background : Globally, the prevalence of allergic rhinitis has increased significantly. However, herbal remedies for allergic rhinitis
were recorded on Wat Pho’s marble inscription in 1832, yet have never been scientifically studied.
Objective : To identify the safe and appropriate dose of an herbal remedy comprising six herbs in healthy adults, and to explore the
safety and preliminary efficacy of the remedy.
Materials and Methods: Phase I, a randomized, non-blinded study focusing on safety of the studied drug included 16 healthy
participants. Phase IIa, a randomized, double-blind, placebo-controlled trial, included 44 patients with persistent allergic rhinitis.
Results : Generally the Thai herbal remedy was safe. However, diarrhea was reported significantly move often in the group that
received the remedy than in the placebo group (p = 0.029). The appropriate dose was determined to be two capsules (1.12 g) after
meals, three times per day. Preliminary efficacy according to symptom-score evaluation by a physician revealed significant
improvements in 3 symptoms. The more than 25% improvement in peak nasal inspiratory flow was detected in participants who
received herbal remedy (p = 0.018).
Conclusion : This herbal remedy was well tolerated, with a somewhat increased occurrence of diarrhea. Although the study showed
some symptom improvement.
Keywords : Thai herbal remedy, Allergic rhinitis, Clinical trial, Safety, Efficacy
