A Comparative Study of the Clinical Efficacy and Safety of Benjakul Extract and Loratadine in Allergic Rhinitis Patients: Double Blind, Randomized Controlled Trial
Houngiam K, Chanvimalueng W, อรุณพร อิฐรัตน์*, Mukkasombut N
Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat Univeresity, 99/209 Moo 18, Khlong Nueng, Khlong Luang, Pathum Thani 12120, Thailand. Phone: +66-2-9269749, Fax: +66-2-9269749 Email: iarunporn@yahoo.com
บทคัดย่อ
Background: Benjakul remedy (BJK) is a traditional Thai herbal medicine prescribed as an adaptogen and for treatment of several diseases. Previous in vitro study showed that ethanolic extract of BJK exhibited potent anti-allergic activity by reducing the release of β-hexosaminidase in RBL-2H3 cells.
Objective: To investigate the clinical efficacy and safety of BJK extract in allergic rhinitis patients compared with loratadine treatment.
Materials and Methods: A phase 2, double blind clinical trial, randomized controlled trial was designed to investigate efficacy and safety of BJK in mild to moderate allergic rhinitis patients. In the present study, 60 patients diagnosed as allergic rhinitis by otolaryngologist were recruited. The patients were divided into two groups. During six weeks of treatment, the experimental group received 300 mg/day of the BJK extract and the control group was treated with 10 mg/day of loratadine. All patients were followed up at 21 and 42 days. The changes of total nasal symptom score (TNSS), acoustic rhinometry were evaluated as efficacy parameters. Regarding safety issue, clinical signs and symptoms, complete physical examination, and blood chemistries and components were evaluated.
Results: Sixty patients completed this clinical investigation. After treatments, TNSS parameters of both groups decreased from baseline, but the acoustic rhinometry parameters of both groups did not significantly decrease. Between the groups, comparison showed no differences. The blood analysis of both groups did not change after treatments.
Conclusion: Oral administration of 100 mg BJK extract three times daily for 42 days in allergic rhinitis patients can reduce allergic rhinitis symptoms and it showed safety on all parameters.
 
 
ที่มา
วารสารจดหมายเหตุทางการแพทย์ ปี 2562, October ปีที่: 102 ฉบับที่ 10 หน้า 1121-1127
คำสำคัญ
Loratadine, Allergic rhinitis, Benjakul, Phase II, Efficacy and Safety