Kim Kwan-Il, Shin Seungwon, Kim Kyuseok, Lee Junhee
Department of Clinical Korean Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-872, Republic of Korea.
Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-872, Republic of Korea.
BMC Complement Altern Med. 2016 Feb 2;16:46. doi: 10.1186/s12906-016-1028-x.
Chronic cough, defined it lasts more than 8 weeks. The symptom is common, but highly troublesome, and it reduces quality of life. Despite much effort to develop a protocol for diagnosis and treatment of chronic cough, it remains problematic to determine its cause. As a result, treatment is often unsuccessful. Thus, there is much interest regarding the use of symptomatic drugs to control chronic cough. Maekmoondong-tang is widely used in East Asian countries to treat chronic dry cough. Several experimental studies have reported that the herbal medicine has immunomodulatory and antitussive effects. Clinical studies involving Maekmoondong-tang have also been carried out; however, these studies have involved treating various diseases as a whole rather than chronic cough itself. Thus, we aim to evaluate the efficacy and safety of Maekmoondong-tang in chronic dry cough patients with a randomized controlled trial.
METHODS/DESIGN: This study is designed as an exploratory, single-center, placebo-controlled, double-blind, randomized, parallel group clinical trial. Patients with dry cough that has lasted more than 8 weeks will be recruited, after a 1-week run-in period, and randomly allocated to either the Maekmoondong-tang treatment group or the placebo group. The patients will receive Maekmoondong-tang or placebo granules 3 times daily for 4 weeks, with a 2-week follow-up. The primary outcome is a 10-point cough diary that will be recorded on a daily basis. The secondary outcomes comprise a cough visual analog scale, the Leicester Cough Questionnaire (Korean version), the Pattern Identification for Chronic Cough Questionnaire, biomarkers, safety testing, etc. Adverse events will also be reported.
This trial will assess the efficacy and safety of Maekmoondong-tang in chronic dry cough.
Korean Clinical Trial Registry ( http://cris.nih.go.kr ; registration number: KCT0001646). Date of registration: October 5 2015.
慢性咳嗽定义为持续超过8周。该症状很常见，但极为困扰患者，会降低生活质量。尽管人们为制定慢性咳嗽的诊断和治疗方案付出诸多努力，但确定其病因仍存在问题。因此，治疗往往不成功。于是，使用对症药物控制慢性咳嗽备受关注。麦门冬汤在东亚国家被广泛用于治疗慢性干咳。多项实验研究报告称，这种草药具有免疫调节和镇咳作用。也开展了涉及麦门冬汤的临床研究；然而，这些研究是将其用于治疗各种疾病，而非针对慢性咳嗽本身。因此，我们旨在通过一项随机对照试验评估麦门冬汤对慢性干咳患者的疗效和安全性。
方法/设计：本研究设计为一项探索性、单中心、安慰剂对照、双盲、随机、平行组临床试验。干咳持续超过8周的患者将在经过1周导入期后招募，并随机分配至麦门冬汤治疗组或安慰剂组。患者将每日3次服用麦门冬汤或安慰剂颗粒，持续4周，并进行2周的随访。主要结局是每日记录的10分制咳嗽日记。次要结局包括咳嗽视觉模拟量表、莱斯特咳嗽问卷（韩文版）、慢性咳嗽模式识别问卷、生物标志物、安全性检测等。不良事件也将予以报告。
本试验将评估麦门冬汤对慢性干咳的疗效和安全性。
韩国临床试验注册中心（http://cris.nih.go.kr；注册号：KCT0001646）。注册日期：2015年10月5日。
