Exploring the efficacy and safety of topical Jaungo application in patients with atopic dermatitis: A pilot randomized, double-blind, placebo-controlled study.

BACKGROUND: Atopic dermatitis (AD) is a chronic relapsing eczematous skin disease with an increasing prevalence. In Korea, Jaungo is a traditional medicinal ointment, which is commonly used for treating skin wounds. OBJECTIVE: Thus, we aim to explore the basic clinical efficacy and safety data for Jaungo in patients with AD. METHODS: This study was a pilot randomized, double-blind, placebo-controlled, single-center trial with three groups. The participants in treatment group 1 applied Jaungo to the lesion twice a day for 3 weeks. Those in treatment group 2 applied Jaungo and placebo ointments to the lesion once a day for 3 weeks. Those in the placebo group applied placebo ointments to the lesion twice a day for 3 weeks. The Eczema Area and Severity Index and SCORing Atopic Dermatitis scores, transepidermal water loss value, and Dermatology Life Quality Index score were assessed. The outcomes used to evaluate safety were the Draize score, blood test results, and expert opinion. RESULTS: In total, 28 patients (82.4%) completed the study. During the study, significant decline of EASI scores in treatment group 2 and placebo group was observed (p < 0.05). And there was significant decline of SCORAD scores in treatment group1 and placebo group (p < 0.05). Patients in all groups showed decreased TEWL and DLQI scores with no significant difference. There was significant decline of IL-17 in all groups (p < 0.05). No serious adverse event was observed. CONCLUSION: This is the first study that has explored the potential therapeutic effect of Jaungo as a complementary therapy for AD. However, further large study with adjusting placebo ingredients is needed to confirm the effectiveness of Jaungo in patients with chronic-phase AD.

Efficacy and safety of So-Cheong-Ryong-Tang in treatment of perennial allergic rhinitis: study protocol for a double-blind, randomised, parallel-group, multicentre trial.

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT03009136; Pre-results.

Topical application of Jaungo in atopic dermatitis patients: study protocol for a randomized, controlled trial.

BACKGROUND: Atopic dermatitis (AD) is a common pruritic inflammatory skin disease with increasing prevalence. It can manifest with many different clinical phenotypes; however, in its chronic stage, hyperpigmentation, excoriation, lichenification, and dryness are the main symptoms. Jaungo comprises two herbs, Lithospermi radix and Angelica gigantis radix, and three carrier oils, and is an approved herbal ointment for xerosis cutis in Korea. In past studies, we demonstrated that Jaungo had anti-inflammatory and antiallergic activity in in vitro and in vivo AD models; however, there are few relevant randomized controlled clinical trials on Jaungo in AD. METHODS/DESIGN: A randomized, double-blind, placebo-controlled, single-center, phase IIa clinical trial was designed to investigate the safety, preliminary efficacy, and dose response of Jaungo in AD. The study protocol was approved by the Institutional Review Boards of the Kyung Hee University Korean Medicine Hospital (No. KOMCIRB-160617-HR-027) and the Korea Food and Drug Administration (No. 30907). The study aims to enroll 34 AD patients to be randomly distributed among three parallel groups: treatment 1, treatment 2, and the placebo group. Treatment group 1 applies Jaungo twice a day, while treatment group 2 applies Jaungo and the placebo ointment once a day, separately, and the placebo group applies the placebo ointment twice a day, for a total of 3 weeks each. Participants will be evaluated for eczema before and after the application of the ointments based on several parameters including the Eczema Area and Severity Index, the SCORing of Atopic Dermatitis Index, the Dermatology Life Quality Index, transepidermal water loss, total IgE level, eosinophil count, and IL-17, IL-22, and IFN-γ levels. DISCUSSION: The trial is currently ongoing and the enrollment of subjects has been initiated. There is an urgent need to develop a drug for the treatment of dry, hyperpigmented, scaly, and thickened skin in chronic-stage AD. This study will determine the efficacy and safety of Jaungo in AD, providing evidence for specific AD symptoms treated by Jaungo. TRIAL REGISTRATION: Clinical Trials.gov, identifier: NCT02900131 . Registered on 2 September 2016. Korea Clinical Research Information Service, identifier: KCT0002060 . Registered on 22 July 2016.