Modified Gwakjeongtang for Diarrhea-Predominant Irritable Bowel Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Pilot Clinical Trial

Overview

Journal Int J Gen Med

Publisher Dove Medical Press

Specialty General Medicine

Date 2024 Apr 29

PMID 38680195

Authors

Yujin Choi

Na-Yeon Ha

Ae-Ran Kim

Haein Jeong

Ojin Kwon

Ki-Sun Park

Jieun Kim

Jinsung Kim

Hyungjun Kim

Affiliations

Soon will be listed here.

Abstract

Introduction: 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).

References

Mulak A, Bonaz B . Irritable bowel syndrome: a model of the brain-gut interactions. Med Sci Monit. 2004; 10(4):RA55-62. View

Ko S, Ryu B, Kim J, Hong B, Yeo I, Lee B . Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial. Trials. 2011; 12:219. PMC: 3198690. DOI: 10.1186/1745-6215-12-219. View

Park J, Ko S, Han G, Kim K, Jun H, Park J . Gwakhyangjeonggi-san for irritable bowel syndrome: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021; 100(27):e26635. PMC: 8270575. DOI: 10.1097/MD.0000000000026635. View

Patrick D, Drossman D, Frederick I, DiCesare J, Puder K . Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998; 43(2):400-11. DOI: 10.1023/a:1018831127942. View

Lydiard R . Irritable bowel syndrome, anxiety, and depression: what are the links?. J Clin Psychiatry. 2002; 62 Suppl 8:38-45; discussion 46-7. View

Choi Y, Cho J, Lee D, Song D, Kwon Y, Baek S . [Development of Koreans Gut Quotient Measurement Scales]. Korean J Gastroenterol. 2019; 73(6):341-349. DOI: 10.4166/kjg.2019.73.6.341. View

Skevington S, Lotfy M, OConnell K . The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004; 13(2):299-310. DOI: 10.1023/B:QURE.0000018486.91360.00. View

Lawrence E, Shaw P, Baker D, Baron-Cohen S, David A . Measuring empathy: reliability and validity of the Empathy Quotient. Psychol Med. 2004; 34(5):911-9. DOI: 10.1017/s0033291703001624. View

Dimberg U, Thunberg M . Empathy, emotional contagion, and rapid facial reactions to angry and happy facial expressions. Psych J. 2015; 1(2):118-27. DOI: 10.1002/pchj.4. View

10.

Lewis S, Heaton K . Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997; 32(9):920-4. DOI: 10.3109/00365529709011203. View

11.

Ko S, Han G, Kim S, Seo J, Chung W, Ryu B . Effect of korean herbal medicine combined with a probiotic mixture on diarrhea-dominant irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial. Evid Based Complement Alternat Med. 2014; 2013:824605. PMC: 3870130. DOI: 10.1155/2013/824605. View

12.

Francis C, Morris J, Whorwell P . The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997; 11(2):395-402. DOI: 10.1046/j.1365-2036.1997.142318000.x. View

13.

Svedlund J, Sjodin I, DOTEVALL G . GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988; 33(2):129-34. DOI: 10.1007/BF01535722. View

14.

Drossman D, Hasler W . Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016; 150(6):1257-61. DOI: 10.1053/j.gastro.2016.03.035. View

15.

Dai L, Cheng C, Tian R, Ld Zhong L, Li Y, Lyu A . Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med. 2018; 25(1):71-79. DOI: 10.1007/s11655-018-2999-x. View

16.

Xie Y, Tang F . [Experimental study on protecting intestinal barrier function of Huoxiang Zhengqi soft capsule]. Zhongguo Zhong Yao Za Zhi. 2005; 29(5):456-8. View

17.

Camilleri M . Diagnosis and Treatment of Irritable Bowel Syndrome: A Review. JAMA. 2021; 325(9):865-877. DOI: 10.1001/jama.2020.22532. View

18.

Liu J, Yang M, Liu Y, Wei M, Grimsgaard S . Herbal medicines for treatment of irritable bowel syndrome. Cochrane Database Syst Rev. 2006; (1):CD004116. DOI: 10.1002/14651858.CD004116.pub2. View

19.

Bashashati M, Rezaei N, Shafieyoun A, McKernan D, Chang L, Ohman L . Cytokine imbalance in irritable bowel syndrome: a systematic review and meta-analysis. Neurogastroenterol Motil. 2014; 26(7):1036-48. DOI: 10.1111/nmo.12358. View

20.

Palsson O, Whitehead W, Tornblom H, Sperber A, Simren M . Prevalence of Rome IV Functional Bowel Disorders Among Adults in the United States, Canada, and the United Kingdom. Gastroenterology. 2020; 158(5):1262-1273.e3. DOI: 10.1053/j.gastro.2019.12.021. View