This study is designed to investigate the objective effects of Hyangsapyeongwisan on functional dyspepsia

Effect of Hyangsapyeongwisan on Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000066

Enrollment

170

Registered

2010-12-22

Start date

2009-12-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Each 9.68g Hyangsapyeongwisan granule is composed of 9 herbs: Atractylodes japonica extract 2.67g, Magnolia officinalis extract 0.47g, Citrus aurantium extract 1.33g, Glycyrrhiza uralensis extr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria for this study were as follows; ? All men and women aged between 20 and 70 years ? All of the patients who meet the definition of the Rome ? ? Patients with more than 2 moderate symptoms of epigastric pain, epigastric discomfort, epigastric burning, early satiety, postprandial fullness, epigastric pressure sense, epigastric bloating and nausea, and a total score or higher based on the following scale for each symptom: ? 0 absence of the symptom. ? 1 mild symptom: patients feel the symptoms during the medical examination of physicians but no treatment is required. ? 2 moderate symptom: patients feel the symptoms but they seldom interfere with normal daily activities ? 3 severe symptom: patients feel the symptoms interfere with normal daily activities

Exclusion criteria

Exclusion criteria: Patients who report the following conditions will be excluded; ? History of gastrointestinal surgery (except, appendectomy) ? Patients at risk from gastrointestinal motility for reasons such as gastrointestinal bleeding, mechanical obstruction, or perforation ? The presence of a disease causing different results in the evaluation of the digestive system within the past two years ? Ingestion of drugs that affect the results of the research drug ? Liver cancer or cirrhosis, chronic renal failure, congestive heart failure ? Women who are pregnant, lactating, or who are of childbearing age and do not use an appropriate contraceptive method.

Design outcomes

Primary

Measure	Time frame
The changes of total score of before and after the trial on the 8 symptoms high correlate with dyspepsia at the NDI score of symptoms	—

Secondary

Measure	Time frame
The changes of NDI 15 symptom score before and after the trial;The changes of NDI 15 symptom total score of before and after the trial;The changes of quality of life score by domains of NDI before and after the trial;The changes of quality of life total score of NDI before and after the trial;The changes of quality of life total score of FD-QOL before and after the trial;The changes of quality of life of FD-QOL score by domains before and after the trial;Symptom improvement rate: According to decreasing total score of primary endpoint NDI 8 dyspeptic symptoms	—

Measure

Time frame

The changes of NDI 15 symptom score before and after the trial;The changes of NDI 15 symptom total score of before and after the trial;The changes of quality of life score by domains of NDI before and after the trial;The changes of quality of life total score of NDI before and after the trial;The changes of quality of life total score of FD-QOL before and after the trial;The changes of quality of life of FD-QOL score by domains before and after the trial;Symptom improvement rate: According to decreasing total score of primary endpoint NDI 8 dyspeptic symptoms

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Countries

Korea, Republic of

Contacts

Public ContactJung Cho

Daejeon University

Outcome results