Kim Min-Hee, Ko Youme, Ahn Jin-Hyang, Yun Younghee, Yun Mi-Na, Ko Seong-Gyu, Choi Inhwa
Department of Ophthalmology, Otorhinolaryngology, and Dermatology of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.
Department of Clinical Korean Medicine, Graduate school, Kyung Hee University, Seoul, Republic of Korea.
BMJ Open. 2017 Sep 27;7(9):e016556. doi: 10.1136/bmjopen-2017-016556.
So-Cheong-Ryong-Tang (SCRT) is a herbal medicine widely used in traditional medicine for treating allergic rhinitis (AR). In animal studies, SCRT has suppressed the progression of AR. The main purpose of this study is to assess the efficacy and safety of the SCRT for the treatment of perennial allergic rhinitis (PAR) and discover the underlying mechanisms resulting in anti-inflammatory effects in humans.
We will conduct a double-blind, randomised, placebo-controlled, parallel-group, multicentre trial of Korean adults with PAR. For the study, 156 subjects with PAR will be recruited. The trial will consist of a 4-week oral administration of SCRT or placebo with two visits at 2-week intervals and an 8-week follow-up period with two visits at 4-week intervals. The primary outcome is a change in the total nasal symptoms score. The secondary outcomes include changes in the Rhinoconjunctivitis Quality of Life Questionnaire score, total serum IgE and cytokines levels.
This study was approved by the Institutional Review Board at each research centre (name of each centres and approval numbers): Kyung Hee University Hospital at Gangdong (KHNMC-OH-IRB 2015-04-009), Kyung Hee University Medical Centre (KOMCIRB-160321-HRBR-011), Pusan National University Hospital (2016-004), Dongguk University Medical Centre (2016-03) and Semyung University hospital (2016-01). This result will be published in a peer-reviewed journal.
NCT03009136; Pre-results.
苏贞龙汤（SCRT）是一种在传统医学中广泛用于治疗过敏性鼻炎（AR）的草药。在动物研究中，SCRT抑制了AR的进展。本研究的主要目的是评估SCRT治疗常年性过敏性鼻炎（PAR）的疗效和安全性，并发现其在人体中产生抗炎作用的潜在机制。
我们将对患有PAR的韩国成年人进行一项双盲、随机、安慰剂对照、平行组、多中心试验。对于该研究，将招募156名患有PAR的受试者。试验将包括为期4周的SCRT或安慰剂口服给药，每2周进行两次访视，以及为期8周的随访期，每4周进行两次访视。主要结局是总鼻症状评分的变化。次要结局包括变应性鼻炎生活质量问卷评分、总血清IgE和细胞因子水平的变化。
本研究已获得各研究中心机构审查委员会的批准（各中心名称及批准号）：江东庆熙大学医院（KHNMC-OH-IRB 2015-04-009）、庆熙大学医学中心（KOMCIRB-160321-HRBR-011）、釜山国立大学医院（2016-004）、东国大学医学中心（2016-03）和 seminung大学医院（2016-01）。该结果将发表在同行评审期刊上。
NCT03009136；预结果。
