Efficacy of Banha-sasim-tang on functional dyspepsia classified as excess pattern: study protocol for a randomized controlled trial
نویسندگان
چکیده
BACKGROUND Functional dyspepsia (FD) refers to the presence of one or more gastrointestinal symptoms including postprandial fullness, epigastric pain, burning, and early satiety without an organic explanation for chronic symptoms. FD causes considerable discomfort in patients and affects their everyday activity and productivity. Because most conventional treatments have limited efficacy, numerous patients seek alternatives such as herbal medicines. In this proposed study, we will conduct a clinical trial of an herbal drug, Banha-sasim-tang (BST). Furthermore, participants will be limited to those classified as having an excess pattern by using an instrument of pattern identification for FD to determine the efficacy of BST in a specific subset of patients. METHODS This randomized, blinded, parallel-group clinical trial of BST versus placebo will consist of 4 weeks of oral administration of BST or placebo and a 4-week follow-up period. The Korean version of the symptom-based questionnaire of the Nepean Dyspepsia Index (NDI-K) will be used as the primary outcome measure. Secondary outcome measures will include the quality-of-life (QoL) evaluation from the NDI-K, the FD-related QoL (FD-QoL) scale, assessment of gastric myoelectrical dysrhythmias (GMA), and a Visual Analog Scale (VAS) analysis. DISCUSSION The results of this trial are expected to provide relevant evidence demonstrating that BST can be used as an effective treatment in a specific subset of FD subjects. TRIAL REGISTRATION KCT 0002013 . Registered at Clinical Research Information Service in the Republic of Korea on 18 August 2016.
منابع مشابه
Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial
BACKGROUND Functional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventional treatments. Alternative therapies, such as herbal formulas, are widely used to treat FD. However, there are inadequate evidences regarding the safety and efficacy of these formulas. Moreover, the mechanisms by which herbal formulas act in the gastrointestinal tract are controversial. In ...
متن کاملAuthor's response to reviews Title: Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial Authors:
متن کامل
P02.103. Banha-sasim-tang, a herbal formula, for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial
Purpose Functional dyspepsia (FD) is a chronic gastrointestinal disorder characterized by dyspeptic symptoms without structural lesions. There are no standard treatments for FD until now. Thus, many researchers had been interested in alternative therapies, including herbal formulas, for FD treatment. However, alternative therapies need more evidence. In traditional Korean medicine, Banhasasim-t...
متن کاملThe Effects of Banha-sasim-tang on Dyspeptic Symptoms and Gastric Motility in Cases of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled, and Two-Center Trial
Introduction. Functional dyspepsia (FD) is highly prevalent, and no standard treatments exist for this condition. Herbal prescriptions are widely used to treat FD. In traditional Korean medicine, Banha-sasim-tang (BST) is a famous herbal prescription for dyspepsia. This study aimed to evaluate the efficacy of BST and to examine the relationship between gastric slow waves and dyspeptic symptoms....
متن کاملEffects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial
Introduction. Functional dyspepsia (FD), a common upper gastrointestinal disease, is difficult to manage because of the limitations of current conventional treatments. Yukgunja-tang (YGJT) is widely used to treat FD in clinical practice in Korea, Japan, and China. However, YGJT significantly improves few symptoms of FD. In Korean medicine, FD is a well-known functional gastric disease that show...
متن کامل