Preliminary Study on Safety and Efficacy of a Thai Herbal Remedy in Persistent Allergic Rhinitis: A Randomized Double-blind Placebo-controlled Trial
Sasithorn Tandhavadhana, Maek-A-Nantawat W, Phonrat B, Picheansoonthon C, Pitisuttithum P*
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, 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.
วารสารจดหมายเหตุทางการแพทย์ ปี 2562, August ปีที่: 102 ฉบับที่ Suppl 7 หน้า 24-29
Efficacy, Safety, Clinical trial, Allergic rhinitis, Efficacy, Thai herbal remedy