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Completed

NCT Number: NCT00987805

Efficacy of Banhasasim-tang on Functional Dyspepsia

The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and safety based on the rate of adverse event or laboratory findings of Banhasasim-tang administrated three times a day orally on functional dyspepsia.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

East-West Neo Medical Center, Seoul, South Korea

Loading trial locations.

About this study

Banhasasim-tang

  • Main 3 gram herb powder (including Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma) of old oriental prescriptions for dyspepsia.
  • Usually having used for dyspepsia in asia
  • Need for correct clinical information by RCT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Typical functional dyspepsia according to ROME III criteria.
  • One or more of:
  • Bothersome post-prandial fullness
  • Early satiation
  • Epigastric pain
  • Epigastric burning
  • No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
  • The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms
  • Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks
  • Written and informed consent

Exclusion criteria

  • History of peptic ulcer or gastroesophageal reflux disease(GERD)
  • Current prominent symptoms of irritable bowel syndrome or GERD
  • Presence of the following alarm symptoms:
  • Severe weight loss
  • Black or tar stool
  • Dysphagia
  • Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders
  • Women in pregnancy and lactation
  • History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system
  • Participation of other clinical trials within the last 3 months
  • Severe mental problems or drug abuse
  • Judged by expert that they are appropriate to participate in this study

Treatment and study plan

Banhasasim-tang

Dietary Supplement

Form : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study

Other names: Brand names : Bansasin granules

Corn-starch granules

Dietary Supplement

This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.

Other names: Corn-starch granules with herb decoctions flavor

Primary outcomes

  1. Gastrointestinal Symptom (GIS) score (epigastric pain/upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort, and acidic regurgitation/heartburn)

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish

Secondary outcomes

  1. Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia

    Time frame: Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish

  2. Functional Dyspepsia-related Quality of Life (FD-QoL)

    Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish

  3. Electrogastrography (EGG)

    Time frame: Baseline, 6 weeks after administration

Sponsors and collaborators

Lead sponsor

Korea Health Industry Development Institute

Other Gov

Registry information

Official study title

Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2009
Registry last updated
Jun 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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