Modified Gwakjeongtang for Diarrhea-Predominant Irritable Bowel Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Pilot Clinical Trial
Yujin Choi,1,* Na-Yeon Ha,2,* Ae-Ran Kim,3 Haein Jeong,2 Ojin Kwon,1 Ki-Sun Park,1 Jieun Kim,1 Jinsung Kim,2 Hyungjun Kim1 1KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 2Division of Digestive Diseases, Department of Korean Internal Medicine, Kyung Hee University College of Korean Medicine, Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea; 3R&D Strategy Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea*These authors contributed equally to this workCorrespondence: Jinsung Kim, Department of Digestive Diseases, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea, Tel +82 2 958 8895, Email [email protected] Hyungjun Kim, Division of KM Science Research, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea, Tel +82 42 869 2796, Email [email protected]: Irritable bowel syndrome (IBS) is a chronic condition characterized by recurrent abdominal pain associated with bowel movements. Modified Gwakjeongtang (MGT), an herbal prescription rooted in traditional East Asian medicine, consists of thirteen botanical drugs known for their potential to enhance intestinal barrier function, regulate gastrointestinal motility, and exhibit anti-inflammatory and antioxidant properties. Despite a few previous clinical trials highlighting MGT’s potential for IBS symptom management, limited evidence exists with placebo control.Methods and Analysis: In this pilot randomized clinical trial protocol, we aim to exploratively evaluate the efficacy and safety of MGT in patients with diarrhea-predominant IBS (IBS-D) by comparing it with a placebo. A total of 60 IBS-D patients will be enrolled, and eligible participants will be randomly allocated to either the MGT or placebo groups. Over a 4-week period, they will receive MGT or placebo granules three times a day. The primary endpoint will be the overall response rate post-treatment, determined through daily assessments of abdominal pain intensity and stool consistency.Ethics and Dissemination: This clinical trial protocol has received approval from the Korean Ministry of Food and Drug Safety for an investigational new drug application and Institutional Review Board of the Kyung Hee University Korean Medicine Hospital. The research findings will be submitted and published in international peer-reviewed journal.Trial Registration: Clinical research information service (registration number: KCT0008523).Keywords: irritable bowel syndrome, herbal medicine, Gwakhyang-Jeonggi-San, Huoxiang-Zhengqi-San, Kkako-Shoki-San, clinical protoco
